# K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Aug 30, 2005 after 103 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories: named in the summary without a submission number

## 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-0696-2019: 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
- Apr 2, 2007 · Not classified · Z-0980-2007: The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cyc

## Indications for use
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Source page: https://510kreport.com/device/K051301
Methodology: https://510kreport.com/methodology