# K183477: easyPPHTM Hemorrhoidal Stapler for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Ezisurg Medical Co., Ltd.
- Decided: Feb 11, 2019 after 56 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: 4 generations back to K940967 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
4 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030411: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03, Ethicon Endo-Surgery, Inc. (2003) Summary page 5.

## Indications for use
The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal canal to perform surgical treatment of hemorhoidal disease.

Source page: https://510kreport.com/device/K183477
Methodology: https://510kreport.com/methodology