# K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 22, 2023 after 261 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: 4 generations back to K024275 (2003). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182475: Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters), Covidien (2019) Summary page 6.
- K192330: EEA Circular Stapler with Tri-Staple Technology, Covidien (2020) Summary page 6.

## Most influential descendants
- K253527: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (2026), 0 descendants of its own
- K240881: Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K221629
Methodology: https://510kreport.com/methodology