510(k) K081146 ยท GDW Staple, Implantable
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 26, 2008 |
| Received | Apr 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.