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 · GDW Staple, Implantable
Cleared on Apr 29, 2022 as substantially equivalent to K202701 (Covidien, 2020) and 1 other predicate after a 24-day review. Its family tree reaches back 13 generations to 1985. 1 later device descends from it.
- Decided
- Apr 29, 2022
- Review
- 24 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K842066 (1985). 45 ancestors in all, the oldest K843034 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations between
- 3 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 2 generations backK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 1 generation backK202701 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- This deviceK221006 GIA Stapler with Tri-Staple TechnologyCovidien · 2022
- Descendant · cites it directly · 0 of its ownK231934 GIA™ Stapler with Tri-Staple™ TechnologyCovidien · 2023
Show all 13 generations
- Root · 13 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 12 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 10 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 9 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 8 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 7 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 6 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 5 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 4 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 3 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 2 generations backK192720 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- 1 generation backK202701 GIA Stapler with Tri-Staple TechnologyCovidien · 2020
- This deviceK221006 GIA Stapler with Tri-Staple TechnologyCovidien · 2022
Most influential descendants
Showing 1 of 1 · See all- K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −12 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −10 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −9 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −8 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −7 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −6 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −5 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −4 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| −3 | 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 | K192720 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −1 | K202701 | GIA Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| 0 (this device) | K221006 | GIA Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 15.1 · 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? (2)
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 |
|---|---|---|---|
| * | K202701 | GIA Stapler with Tri-Staple TechnologySummary page 4…ers: GIA60MTS, GIA60XTS, GIA60MTC, GIA60XTC GIA80MTS, GIA80XTS, GIA80MTC, GIA80XTC 510(k) Number: K202701 (Primary Predicate Device) K192720 Classification Name: Staple, Implantable Regula… | 2020 |
| * | K192720 | GIA Stapler with Tri-Staple TechnologySummary page 4…GIA80MTS, GIA80XTS, GIA80MTC, GIA80XTC 510(k) Number: K202701 (Primary Predicate Device) K192720 Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes:… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231934 | GIA™ Stapler with Tri-Staple™ Technology | 2023 | 0 |
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 37 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 45 ancestors have a recall of any class.
- Of its descendants, K231934 (Covidien, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 GIA™ stapler with Tri‑Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221006 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221006: GIA Stapler with Tri-Staple Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221006
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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