510(k) K160521 ยท GDW Staple, Implantable
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Mar 22, 2016 |
| Received | Feb 25, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.