# K030925: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: May 15, 2003 after 52 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940967 (1994). 3 ancestors in all.
22 later devices descend from it; 2 cite it directly.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991030: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.

## Most influential descendants
- K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L (2009), 21 descendants of its own
- K120179: Reach Surgical Staplers (2012), 17 descendants of its own
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr (2013), 14 descendants of its own
- K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads (2014), 7 descendants of its own
- K173443: AEON Endoscopic Stapler (2018), 5 descendants of its own

## Recalls of this device
- Dec 7, 2018 · Class II · Z-0695-2019: Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
- Aug 3, 2012 · Class I · Z-0057-2013: Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Sta

## Indications for use
The PROXIMATE@ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomuscular tissue.

Source page: https://510kreport.com/device/K030925
Methodology: https://510kreport.com/methodology