510(k) · Cleared
Recalled · Class II · 2012Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Group LP · GDW Staple, Implantable
Cleared on May 5, 2008 as substantially equivalent to K061095 (United States Surgical, A Division of Tyco Healthc, 2006) and 3 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1985. 48 later devices descend from it. It has been recalled 24 times.
- Decided
- May 5, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 24
- Predicates
- 4
Its longest line of descent runs back 8 generations to K842066 (1985). 25 ancestors in all. 48 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 5 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 4 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 3 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- This deviceK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008
- Descendant · cites it directly · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- Descendant · cites it directly · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- Descendant · 3 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
2010high 6 (2017) · low 0 (2024)2026
Most influential descendants
Showing 5 of 48 · See all- K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · cites it directly45descendants
- K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · cites it directly44descendants
- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 2 generations on8descendants
- K160176Signia StaplerCovidien · 2016 · 3 generations on5descendants
- K192720GIA Stapler with Tri-Staple TechnologyCovidien · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −7 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −5 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −4 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −3 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| 0 (this device) | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | — |
| +1 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| +1 | 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 | 73 |
| +2 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| +3 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| +2 | K192720 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 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? (4)
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…Surgical Stapler with Implantable Staple CLASSIFICATION NAME: Staple, Implantable PREDICATE DEVICE(S): Autosuture T M ENDO GIA T M Stapler (K061095) Monofilament BIOSYNTM Suture (K000037) Gore SEAMGUARD ® Bioabs… | 2006 |
| * | K000037 | Monofilament Biosyn SutureSummary page 1…Staple, Implantable PREDICATE DEVICE(S): Autosuture T M ENDO GIA T M Stapler (K061095) Monofilament BIOSYNTM Suture (K000037) Gore SEAMGUARD ® Bioabsorbable Staple Line Reinforcement (K043… | 2000 |
| * | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 1…Monofilament BIOSYNTM Suture (K000037) Gore SEAMGUARD ® Bioabsorbable Staple Line Reinforcement (K043056) Synovis Peri-Strips® Staple Line Reinforcement (K040119) DEVICE DESCRIPTION: The… | 2004 |
| * | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Summary page 1…ARD ® Bioabsorbable Staple Line Reinforcement (K043056) Synovis Peri-Strips® Staple Line Reinforcement (K040119) DEVICE DESCRIPTION: The Autosuture TM ENDO GIA T M Staplers with ENDO GIA T M Sin… | 2004 |
What descends from it? (48)
See all 484 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | 2010 | 45 |
| K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)… | 2011 | 44 |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | 2015 | 2 |
| K120258 | Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and… | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2012 | Class II | Z-2436-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications |
| Aug 21, 2012 | Class II | Z-2439-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. |
| Aug 21, 2012 | Class II | Z-2437-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications |
| Aug 21, 2012 | Class II | Z-2435-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications |
| Aug 21, 2012 | Class II | Z-2432-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications |
| Aug 21, 2012 | Class II | Z-2438-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications |
| Aug 21, 2012 | Class II | Z-2434-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. |
| Aug 21, 2012 | Class II | Z-2433-2012 | Device Design | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. |
| Feb 16, 2012 | Not classified | Z-1227-2012 | Process control | Missing component results in the stapler not firing. |
| Jan 12, 2012 | Not classified | Z-0992-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0993-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0995-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0991-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0994-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0996-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Jan 12, 2012 | Not classified | Z-0998-2012 | Under Investigation by firm | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
| Aug 15, 2011 | Not classified | Z-3167-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3169-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3170-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3165-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3171-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3168-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3166-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
| Aug 15, 2011 | Not classified | Z-3164-2011 | Storage | Sterility of the device is compromised due to a breach in the sterile packaging |
The 5 latest of 24 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 23 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K103263 (Covidien, Formerly US Surgical A Divison of Tyco H, 2010) has gone furthest, with 45 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. 2008, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2007high 15 (2014) · low 2 (2024)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
2007high 267 (2023) · low 27 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
2007high 22 (2009) · low 0 (2008)2026
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
2007high 16,600 (2019) · low 2,380 (2008)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?
The Autosuture TM ENDO GIA T M Staplers with ENDO GIA TM Single Use Loading Units with Staple Line Reinforcement 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080898
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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