# K221771: EEA Circular Stapler with Tri-Staple Technology

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Nov 30, 2022 after 162 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K024275 (2003). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202507: EEA Circular Stapler with Tri-Staple Technology, Covidien (2021) Summary page 4.
- K221005: EEA Circular Stapler with Tri-Staple Technology, Covidien (2022) Summary page 4.

## 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
- K232126: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil (2023), 0 descendants of its own

## Indications for use
The EEA™ circular stapler with Tri-Staple™ technology has application 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/K221771
Methodology: https://510kreport.com/methodology