510(k) · Cleared
ClearedEndo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology
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 Nov 22, 2010 as substantially equivalent to K083519 (Covidien Lp, Formerly Registered AS United States, 2009) and 4 other predicates after an 18-day review. Its family tree reaches back 9 generations to 1985. 45 later devices descend from it.
- Decided
- Nov 22, 2010
- Review
- 18 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K842066 (1985). 32 ancestors in all. 45 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations between
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- This deviceK103263 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
- Descendant · 2 generations on · 3 of its ownK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
Show all 9 generations
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- This deviceK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- 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
- K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −8 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −6 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −5 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −1 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| 0 (this device) | 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 | — |
| +2 | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear… | Victor Medical Instruments Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K083519 | Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsSummary page 1…Surgical Stapler with Implantable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): Endo GIA TM Stapler (K083519, K093410, K101444, K(080898) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri… | 2009 |
| * | K093410 | Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologySummary page 1…l Stapler with Implantable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): Endo GIA TM Stapler (K083519, K093410, K101444, K(080898) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-… | 2009 |
| * | K101444 | Autosuture Endo Gia Single Use Tan Reload with Tri-Staple TechnologySummary page 1…with Implantable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): Endo GIA TM Stapler (K083519, K093410, K101444, K(080898) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-… | 2010 |
| * | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Summary page 1…ntable Staples CLASSIFICATION NAME: Staples, Implantable PREDICATE DEVICE(S): Endo GIA TM Stapler (K083519, K093410, K101444, K(080898) DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-… | 2008 |
| * | K090419 | Sils Stitch Endoscopic Suturing DeviceSummary page 1…Endo GIA TM Reloads with Tni-Staple TM Technology described in predicate submissions K(083519 and K(090419 with the exception that the Reloads have pre-attached staple line reinforcement… | 2009 |
What descends from it? (45)
See all 452 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K111825 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) has gone furthest, with 44 descendants of its own.
- 5 other devices also cite its predicate K083519.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Endo GIA™ Staplers with Endo GIA™ Single Use Duet TRS™ Reloads with Tri-Staple™ 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103263
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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