# K103672: Reusable PPH Circular Stapler Handle, PPH Circular Stapler Reload & Accessory Set

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Apr 8, 2011 after 113 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: 1 generation back to K051301 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.

## Indications for use
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Source page: https://510kreport.com/device/K103672
Methodology: https://510kreport.com/methodology