510(k) · Cleared
Recalled · Class II · 2020Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly US Surgical A Divison of Tyco H · GDW Staple, Implantable
Cleared on Oct 25, 2011 as substantially equivalent to K061095 (United States Surgical, A Division of Tyco Healthc, 2006) and 8 other predicates after a 119-day review. Its family tree reaches back 10 generations to 1985. 44 later devices descend from it. It has been recalled 73 times.
- Decided
- Oct 25, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 73
- Predicates
- 9
Its longest line of descent runs back 10 generations to K842066 (1985). 42 ancestors in all, the oldest K843034 (1984). 44 later devices descend from it, 22 citing it directly.
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations between
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 1 generation backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- This deviceK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011
- Descendant · cites it directly · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- Descendant · 2 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- Descendant · cites it directly · 3 of its ownK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK132581 Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple…Cardica, Inc. · 2014 · Recalled
Show all 10 generations
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 7 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 6 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 5 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 1 generation backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- This deviceK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · cites it directly8descendants
- K160176Signia StaplerCovidien · 2016 · 2 generations on5descendants
- K192720GIA Stapler with Tri-Staple TechnologyCovidien · 2020 · cites it directly3descendants
- K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd. · 2016 · cites it directly3descendants
- K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc. · 2014 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −9 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −7 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −6 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −5 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −2 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −1 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| 0 (this device) | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | — |
| +1 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| +2 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| +1 | K192720 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| +1 | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear… | Victor Medical Instruments Co., Ltd. | 2016 | — |
| +1 | K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue… | Cardica, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061095 | Auto Sutur Endo Gia StaplersSummary page 1…a. Panel no and product code: 79-GDW b. Regulation no: 21 CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898)… | 2006 |
| * | K083519 | Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsSummary page 1…. Panel no and product code: 79-GDW b. Regulation no: 21 CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898)… | 2009 |
| * | K093410 | Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologySummary page 1…and product code: 79-GDW b. Regulation no: 21 CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898) DST S… | 2009 |
| * | K101444 | Autosuture Endo Gia Single Use Tan Reload with Tri-Staple TechnologySummary page 1…uct code: 79-GDW b. Regulation no: 21 CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898) DST Series m G… | 2010 |
| * | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologySummary page 1…on no: 21 CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898) DST Series m GIAIV Staplers (K032696) DST Seri… | 2010 |
| * | K102291 | Covidien Endo Gia Radial Reload with Tri-Staple TechnologySummary page 1…CFR 878.4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898) DST Series m GIAIV Staplers (K032696) DST Series TM TA… | 2010 |
| * | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Summary page 1…4750 PREDICATE DEVICE(S): Endo GIA T M Staplers (K061095, K083519, K(093410, K101444, K103263,1K102291,1K080898) DST Series m GIAIV Staplers (K032696) DST Series TM TA TM Staple… | 2008 |
| * | K032696 | Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…Summary page 1…083519, K(093410, K101444, K103263,1K102291,1K080898) DST Series m GIAIV Staplers (K032696) DST Series TM TA TM Staplers (K032696) ENDOPATH Linear Cutters a… | 2003 |
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 1…s m GIAIV Staplers (K032696) DST Series TM TA TM Staplers (K032696) ENDOPATH Linear Cutters and Staplers (K070887) Echelon Linear Cutters and Staplers (K070887 DEVICE DESCRIPTION: The Endo GIA T… | 2007 |
What descends from it? (44)
See all 4422 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | 2012 | 8 |
| K192720 | GIA Stapler with Tri-Staple Technology | 2020 | 3 |
| K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and… | 2016 | 3 |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple… | 2014 | 3 |
| K191070 | Signia Small Diameter Reloads | 2019 | 2 |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal… | 2017 | 1 |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient… | 2017 | 1 |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | 2015 | 1 |
| K133938 | Endo Gia Reinforced Reload with Tri-Staple Technology | 2014 | 1 |
| K131705 | Endo Gia Radial Reload with Tri-Staple Technology | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2020 | Class II | Z-0747-2021 | Process control | May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue… |
| Nov 23, 2020 | Class II | Z-0748-2021 | Process control | May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue… |
| Aug 12, 2020 | Class II | Z-0001-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0005-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0004-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0002-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0008-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0007-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0009-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0006-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Aug 12, 2020 | Class II | Z-0003-2021 | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Jan 17, 2020 | Class II | Z-1264-2020 | Package design/selection | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection |
| May 17, 2019 | Class II | Z-1829-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1831-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1834-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1833-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1836-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1825-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1832-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1830-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1827-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1835-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1826-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 17, 2019 | Class II | Z-1828-2019 | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the… |
| May 22, 2018 | Class II | Z-2503-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| May 22, 2018 | Class II | Z-2505-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| May 22, 2018 | Class II | Z-2504-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1855-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1866-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1826-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1840-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1824-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1844-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1859-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1837-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1833-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1852-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1828-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1842-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1822-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1817-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1831-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1843-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1863-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1815-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1849-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1814-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1839-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1850-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Apr 26, 2018 | Class II | Z-1865-2018 | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 42 ancestors have a recall of any class.
- Of its descendants, K121510 (Covidien, Formerly US Surgical A Divison of Tyco H, 2012) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K061095.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
Endo GIA TM Staplers: The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Endo GIA TM Reloads with Tni-Staple TM Technology including Curved Tip Reloads: The Endo GIA TM Ultra Universal Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and…
Read the full statement (556 words)
Endo GIA TM Staplers:
The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Endo GIA TM Reloads with Tni-Staple TM Technology including Curved Tip Reloads:
The Endo GIA TM Ultra Universal Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Endo GIA TM Ultra Universal Staplers when used with the Endo GIA TM Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Duet TRS TM Reloads with Tni-Staple TM Technology including Duet TRS TM Curved Tip Reloads:
The Endo GIA TM Ultra Universal Staplers with Duet TRS TM Reloads with Tni-Staple TM Technology have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Endo GIA TM Ultra Universal Staplers when used with the Duet TRS TM Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The following indications are applicable to the Endo GIA TM Ultra Universal Stapler with Radial Reload with Tri-Staple TM Technology:
The Endo GIA TM Radial Reload with Tni-Staple TM Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection.
It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The following indications are applicable to the Endo GIA TM Universal Stapler with Endo GIA TM Straight and Roticulator TM SULUs:
The Endo GIA TM Universal Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The following indications are applicable to the Endo GIA TM Universal Stapler with Duet TRS TM Reloads:
The Endo GIA TM Ultra Universal Staplers with Duet TRS TM Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
DST Series GIA TM:
The Auto Suture GIA TM Reloadable Staplers and the SGIA TM Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA TM Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
DST Series TA TM:
The Auto Suture TA TM Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111825
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026