510(k) · Cleared
ClearedTri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GAG Stapler, Surgical
Cleared on Jul 1, 2026 as substantially equivalent to K221629 (Covidien, 2023) and 2 other predicates after a 230-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Jul 1, 2026
- Review
- 230 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K024275 (2003). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
- 6 generations backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- 5 generations backK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · Recalled
- 4 generations backK192330 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020
- 3 generations backK202507 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021
- 2 generations backK221005 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- 1 generation backK221771 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- This deviceK253527 Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)…Covidien, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K024275 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| −6 | K062850 | Autosuture Circular Eea Surgical Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −5 | K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018 | 1 |
| −4 | K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −3 | K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2021 | — |
| −2 | K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| −1 | K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| 0 (this device) | K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)… | Covidien, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Summary page 5…GAG, GDW Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ GAG Circular Adapters)… | 2023 |
| * | K202507 | EEA Circular Stapler with Tri-Staple TechnologySummary page 5…irst) Product Code K221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ GAG Circular Adapters) K202507 EEA Circular Stapler with Tri-Staple Technology GDW K221771 EEA Circular Stapler… | 2021 |
| * | K221771 | EEA Circular Stapler with Tri-Staple TechnologySummary page 5…ith Signia™ GAG Circular Adapters) K202507 EEA Circular Stapler with Tri-Staple Technology GDW K221771 EEA Circular Stapler with Tri-Staple Technology GDW… | 2022 |
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 23 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K221629.
How does its category compare?
All GAG devicesGAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253527: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253527
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026