510(k) · Cleared
ClearedTri-Staple 2.0 Intelligent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GDW Staple, Implantable
Cleared on Dec 5, 2016 as substantially equivalent to K111825 (Covidien, Formerly US Surgical A Divison of Tyco H, 2011) and 2 other predicates after a 28-day review. Its family tree reaches back 13 generations to 1985.
- Decided
- Dec 5, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K842066 (1985). 75 ancestors in all, the oldest K801589 (1980). No later device cites it as a predicate yet.
- 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 backK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- 1 generation backK160176 Signia StaplerCovidien · 2016 · Recalled
- This deviceK163098 Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC · 2016
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 backK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- 1 generation backK160176 Signia StaplerCovidien · 2016 · Recalled
- This deviceK163098 Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC · 2016
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 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| −1 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| 0 (this device) | K163098 | Tri-Staple 2.0 Intelligent Cartridge | Covidien, LLC | 2016 | — |
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 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Summary page 4…rtridges and Signia ™ Stapler Common Name: Surgical Stapler with Implantable Staples Classification Name: Staples, Implantable, (79 GDW, 21 CFR 878.4750) 510(k) Number: K111825, K151163, K160176 Manufacturer: Covidien Device Description: The Signia™ Intelligent Loading Units and Tri-Staple™ 2.0 Intelli… | 2011 |
| * | K151163 | Signia Loading Unit, Tri-Staple 2.0 CartridgeSummary page 4…and Signia ™ Stapler Common Name: Surgical Stapler with Implantable Staples Classification Name: Staples, Implantable, (79 GDW, 21 CFR 878.4750) 510(k) Number: K111825, K151163, K160176 Manufacturer: Covidien Device Description: The Signia™ Intelligent Loading Units and Tri-Staple™ 2.0 Intelligent Cart… | 2015 |
| * | K160176 | Signia StaplerSummary page 4…a ™ Stapler Common Name: Surgical Stapler with Implantable Staples Classification Name: Staples, Implantable, (79 GDW, 21 CFR 878.4750) 510(k) Number: K111825, K151163, K160176 Manufacturer: Covidien Device Description: The Signia™ Intelligent Loading Units and Tri-Staple™ 2.0 Intelligent Cartridges pl… | 2016 |
| * | — | Endo GIA™ Gray Articulating Reload Named without a submission number | |
| * | — | Endo GIA™ AutoSuture™ Universal Articulating Loading Unit Named without a submission number |
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 31 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 19 of the 75 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. 2016, 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 Signia™ intelligent loading units-and Tri-Staple™ 2.0 intelligent cartridges have applications in abdominal, gynesologic, pediatric and thoracic surgery for rescction, transection and ercation of anastomosis. They may be used for transection and sesection of liver substance, hepatic vaseulature and biliary structures, and for transection and resection of PANLTEAS,
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/K163098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163098: Tri-Staple 2.0 Intelligent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163098
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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