510(k) K163454 ยท GDW Staple, Implantable
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Jan 5, 2017 |
| Received | Dec 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2024 | Ethicon Endo-Surgery Inc ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. Open, Classified |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.