# K093402: Autosuture Eea Orvil

- Pathway: 510(k) (Special)
- Applicant: Surgical Devices, A Global Business Unit Tyco
- Decided: Nov 12, 2009 after 10 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: 2 generations back to K024275 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024275: Auto Suture Premium Plus Ceea Disposable Stapler, United States Surgical, A Division of Tyco Healthc (2003) Summary page 1.
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.

## Indications for use
The DST Series TM EEATM OrViITM 21 mm device when used with the DST Series TM EEATM 21 mm stapler, the DST Series TM EEATM OrViITM 25 mm device when used with the DST SeriesTM EEATM 25mm stapler, and the DST Series TM EEATM OrViITM 28 mm device when used with the DST SerieSTMEEATM 28 mm stapler 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, including bariatric surgery.

Source page: https://510kreport.com/device/K093402
Methodology: https://510kreport.com/methodology