# K232126: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Aug 16, 2023 after 30 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221771: EEA Circular Stapler with Tri-Staple Technology, Covidien (2022) Summary page 4.
- K221005: EEA Circular Stapler with Tri-Staple Technology, Covidien (2022) Summary page 4.

## Indications for use
The EEA™ Circular Stapler with Tri‐Staple™ Technology and OrVil™ transoral circular stapler anvil have 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/K232126
Methodology: https://510kreport.com/methodology