510(k) K051301 ยท GDW Staple, Implantable
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Aug 30, 2005 |
| Received | May 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051301
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2018 | Ethicon Endo-Surgery Inc PROXIMATE PPH Hemorrhoidal Circular Stapler
Product Code:PPH03
PPH03: The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical tr Terminated |
GDW | None listed |
| Oct 13, 2012 | Ethicon Endo-Surgery Inc Hemorrhoidal Circular Stapler and Accessories 33mm
Product Usage:
The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical tre Terminated |
GDW | None listed |
| Jun 28, 2007 | Ethicon Endo-Surgery Inc Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.