510(k) · Cleared
ClearedTri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GAG Stapler, Surgical
Cleared on Feb 22, 2023 as substantially equivalent to K182475 (Covidien, 2019) and 1 other predicate after a 261-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Feb 22, 2023
- Review
- 261 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K024275 (2003). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
- 3 generations backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- 2 generations backK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · Recalled
- 1 generation backK182475 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple…Covidien · 2019
- This deviceK221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™…Covidien · 2023
- Descendant · cites it directly · 0 of its ownK253527 Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)…Covidien, LLC · 2026
- Descendant · cites it directly · 0 of its ownK240881 Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™…Covidien (Part of Medtronic) · 2024
Most influential descendants
Showing 2 of 2 · See all- K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0…Covidien, LLC · 2026 · cites it directly0descendants
- K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL…Covidien (Part of Medtronic) · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024275 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| −3 | K062850 | Autosuture Circular Eea Surgical Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −2 | K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018 | 1 |
| −1 | K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0… | Covidien | 2019 | — |
| 0 (this device) | K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | Covidien | 2023 | — |
| +1 | K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)… | Covidien, LLC | 2026 | — |
| +1 | K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular… | Covidien (Part of Medtronic) | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads…Summary page 6…Name: Surgical Stapler PREDICATE DEVICES: Primary Predicate Secondary Predicate 510(k) Number K182475 (Mar 14, 2019) K192330 (Jan 23, 2020) Proprietary/Trade Signia Circular Adapters (for use with EEA… | 2019 |
| * | K192330 | EEA Circular Stapler with Tri-Staple TechnologySummary page 6…TE DEVICES: Primary Predicate Secondary Predicate 510(k) Number K182475 (Mar 14, 2019) K192330 (Jan 23, 2020) Proprietary/Trade Signia Circular Adapters (for use with EEA™ circular stapler with Tri- Name… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K253527 (Covidien, LLC, 2026) has gone furthest, with 0 descendants of its own.
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 Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221629
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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