510(k) K030925 ยท GDW Staple, Implantable
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, May 15, 2003 |
| Received | Mar 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2018 | Ethicon Endo-Surgery Inc PROXIMATE HCS Hemorrhoidal Circular Stapler
Product Code: PPH01
PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wa 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.