510(k) · Cleared
ClearedGIA™ Stapler with Tri-Staple™ Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GAG Stapler, Surgical
Cleared on Oct 27, 2023 as substantially equivalent to K221006 (Covidien, 2022) after a 119-day review. Its family tree reaches back 14 generations to 1985.
- Decided
- Oct 27, 2023
- Review
- 119 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K842066 (1985). 46 ancestors in all, the oldest K843034 (1984). No later device cites it as a predicate yet.
- Root · 14 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 10 generations between
- 3 generations backK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 2 generations backK202701 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 1 generation backK221006 GIA Stapler with Tri-Staple TechnologyCovidien · 2022
- This deviceK231934 GIA™ Stapler with Tri-Staple™ TechnologyCovidien · 2023
Show all 14 generations
- Root · 14 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 13 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 12 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 11 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 10 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 9 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 8 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 7 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 6 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 5 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 4 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 3 generations backK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 2 generations backK202701 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 1 generation backK221006 GIA Stapler with Tri-Staple TechnologyCovidien · 2022
- This deviceK231934 GIA™ Stapler with Tri-Staple™ TechnologyCovidien · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −13 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −12 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −11 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −10 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −9 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −8 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −7 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −6 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −5 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| −4 | 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 |
| −3 | K192720 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −2 | K202701 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −1 | K221006 | GIA Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| 0 (this device) | K231934 | GIA™ Stapler with Tri-Staple™ Technology | Covidien | 2023 | — |
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 |
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 GAG? 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 GAG device
- #1 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C)…score 15.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K221006 | GIA Stapler with Tri-Staple TechnologySummary page 5…Surgical stapler with implantable staples Predicate Device: Proprietary/Trade Name: GIATM Stapler with Tri-StapleTM Technology 510(k) Number: K221006 Classification Name: Stapler, Surgical; Staple, Implantable Regulations Number: 21 CFR 878.4740, 21 CFR… | 2022 |
| † | K221013 | GIA Auto Suture Stapler with DST Series Technology | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 46 ancestors have a recall of any class.
How does its category compare?
All GAG devicesGAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GAG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAG
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAG
1,065in 2025
MAUDE reports naming product code GAG, 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 | 0 | — | 0 | 919 |
| 2008 | 0 | — | 0 | 366 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 0 | — | 1 | 22 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 49 |
| 2013 | 0 | — | 0 | 135 |
| 2014 | 0 | — | 0 | 302 |
| 2015 | 0 | — | 0 | 144 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 96 |
| 2018 | 0 | — | 1 | 81 |
| 2019 | 0 | — | 0 | 70 |
| 2020 | 0 | — | 0 | 47 |
| 2021 | 0 | — | 0 | 53 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 4 | 102 | 0 | 109 |
| 2024 | 3 | 138 | 0 | 1,126 |
| 2025 | 2 | — | 0 | 1,065 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231934: GIA™ Stapler with Tri-Staple™ Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231934
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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