# K110049: Reusable Linear Stapler Handle

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Feb 10, 2011 after 34 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: 3 generations back to K821994 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.

## Indications for use
The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues

Source page: https://510kreport.com/device/K110049
Methodology: https://510kreport.com/methodology