510(k) · Cleared
ClearedGIA Auto Suture Stapler with DST Series Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GDW Staple, Implantable
Cleared on May 5, 2022 as substantially equivalent to K111825 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) after a 30-day review. Its family tree reaches back 11 generations to 1985.
- Decided
- May 5, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K842066 (1985). 43 ancestors in all, the oldest K843034 (1984). No later device cites it as a predicate yet.
- Root · 11 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations between
- 3 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 2 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 1 generation backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- This deviceK221013 GIA Auto Suture Stapler with DST Series TechnologyCovidien · 2022
Show all 11 generations
- Root · 11 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 10 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 8 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 7 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 6 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 5 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 3 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 2 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 1 generation backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- This deviceK221013 GIA Auto Suture Stapler with DST Series TechnologyCovidien · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −10 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −8 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −7 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −6 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −5 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −3 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −2 | 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 |
| 0 (this device) | K221013 | GIA Auto Suture Stapler with DST Series Technology | Covidien | 2022 | — |
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 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? (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 |
|---|---|---|---|
| * | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Summary page 4…with Implantable Staples Predicate Device: Proprietary / GIA™ Auto Suture™ Stapler with DST Series™ Technology Trade Name: 510(k) Number: K111825 Classification Name: Staple, Implantable Regulation Number: 21 CFR 878.4750 Product Codes: GDW FD… | 2011 |
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 37 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 43 ancestors have a recall of any class.
- 21 other devices also cite its predicate K111825.
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 reloadable staplers have 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/K221013 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221013: GIA Auto Suture Stapler with DST Series Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221013
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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