510(k) K202665 ยท GDW Staple, Implantable
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
| Applicant | Ethicon Endo-Surgery, LLC, Guaynabo PR, US |
| Decision | Substantially Equivalent, Oct 15, 2020 |
| Received | Sep 14, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2021 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, uro Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.