# K221003: Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 30, 2022 after 178 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 4.
- K221005: EEA Circular Stapler with Tri-Staple Technology, Covidien (2022). Cleared while this submission was under review Summary page 5.
- K202507: EEA Circular Stapler with Tri-Staple Technology, Covidien (2021) Summary page 5.
- K192330: EEA Circular Stapler with Tri-Staple Technology, Covidien (2020) Summary page 5.
- K172361: EEA Circular Stapler with Tri-Staple Technology, Covidien (2018) Summary page 5.

## Indications for use
The circular stapler with DST Series™ 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/K221003
Methodology: https://510kreport.com/methodology