# K253527: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 1, 2026 after 230 days
- Product code: GAG (Stapler, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K024275 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters), Covidien (2023) Summary page 5.
- K202507: EEA Circular Stapler with Tri-Staple Technology, Covidien (2021) Summary page 5.
- K221771: EEA Circular Stapler with Tri-Staple Technology, Covidien (2022) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253527
Methodology: https://510kreport.com/methodology