510(k) · Cleared
ClearedTri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien (Part of Medtronic) · GDW Staple, Implantable
Cleared on Apr 10, 2026 as substantially equivalent to K202864 (Covidien, 2020) and 4 other predicates after a 141-day review. Its family tree reaches back 14 generations to 1985. 4 of the 92 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 10, 2026
- Review
- 141 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K842066 (1985). 91 ancestors in all, the oldest K801589 (1980). No later device cites it as a predicate yet. 4 of the 92 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 10 generations between
- 3 generations backK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- 2 generations backK160176 Signia StaplerCovidien · 2016 · Recalled
- 1 generation backK202864 Tri-Staple 2.0 ReloadsCovidien · 2020
- This deviceK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026
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 backK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- 2 generations backK160176 Signia StaplerCovidien · 2016 · Recalled
- 1 generation backK202864 Tri-Staple 2.0 ReloadsCovidien · 2020
- This deviceK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…direct predicate · 2014
- K081146 Echelon Endoscopic Linear Cutters (Articulating…2 generations back · 2008
- K160521 ECHELON FLEX 60 Powered Plus Compact…3 generations back · 2016
- K140560 Echelon Flex Powered Plus Articulating…3 generations back · 2014
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 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| −2 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| −1 | K202864 | Tri-Staple 2.0 Reloads | Covidien | 2020 | — |
| 0 (this device) | K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo… | Covidien (Part of Medtronic) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 1 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 2 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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.
4 devices in this family have a Class I recall. 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 K250835 ETHICON 4000 60mm Compact Stapler (EC3D60C)…score 14.7 · 9 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 |
|---|---|---|---|
| * | K202864 | Tri-Staple 2.0 ReloadsSummary page 5…Primary Secondary Secondary Predicate 1 Predicate 2 Predicate 3 Predicate 1 Predicate 2 510(k) Number K202864 K111825 K222641 K241629 K141952 Proprietary/Trade Tri-Staple™ Endo GIA™ Signia™… | 2020 |
| * | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Summary page 5…Secondary Secondary Predicate 1 Predicate 2 Predicate 3 Predicate 1 Predicate 2 510(k) Number K202864 K111825 K222641 K241629 K141952 Proprietary/Trade Tri-Staple™ Endo GIA™ Signia™ ECHELON™… | 2011 |
| * | K222641 | Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionSummary page 5…Secondary Predicate 1 Predicate 2 Predicate 3 Predicate 1 Predicate 2 510(k) Number K202864 K111825 K222641 K241629 K141952 Proprietary/Trade Tri-Staple™ Endo GIA™ Signia™ ECHELON™ Echelon Nam… | 2022 |
| * | K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Summary page 5…Predicate 1 Predicate 2 Predicate 3 Predicate 1 Predicate 2 510(k) Number K202864 K111825 K222641 K241629 K141952 Proprietary/Trade Tri-Staple™ Endo GIA™ Signia™ ECHELON™ Echelon Name… | 2024 |
| * | K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Summary page 5…Predicate 1 Predicate 2 Predicate 3 Predicate 1 Predicate 2 510(k) Number K202864 K111825 K222641 K241629 K141952 Proprietary/Trade Tri-Staple™ Endo GIA™ Signia™ ECHELON™ Echelon Name 2.0 Re… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · Direct predicate · ◆ in the 2014 ancestors bar of FIG. 11 Class I recall
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus…Ethicon Endo-Surgery, LLC · 2014 · 3 generations back · ◆ in the 2014 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 41 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 29 of the 91 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Tri‑Staple™ 2.0 reloads are indicated for use in abdominal, urologic, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue. The Endo GIA™…
Read the full statement (206 words)
The Tri‑Staple™ 2.0 reloads are indicated for use in abdominal, urologic, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
The Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue.
The Endo GIA™ Ultra universal short, Endo GIA™ Ultra universal and Endo GIA™ Ultra universal XL staplers and Endo GIA™ reloads with Tri‑Staple™ technology are indicated for use in abdominal, urologic, gynecologic, pediatric, and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
The Endo GIA™ Ultra universal short, Endo GIA™ Ultra universal and Endo GIA™ Ultra universal XL staplers when used with the Endo GIA™ curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
The Signia™ small diameter reloads are indicated for use in abdominal, urologic, gynecologic, pediatric and thoracic surgery for resection and transection of vasculature using gray reloads and thin tissue and vasculature using white reloads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253657
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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