# K111195: Valutrus Reusable Circular Stapler and Disposable Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Aug 3, 2011 after 97 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 K940967 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983536: Proximate Curved and Straight Intraluminal Staplers, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.

## Indications for use
The ValuTrusTM Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Source page: https://510kreport.com/device/K111195
Methodology: https://510kreport.com/methodology