510(k) K961390 ยท OCW Endoscopic Tissue Approximation Device
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 25, 1996 |
| Received | Apr 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2003 | Ethicon Endo-Surgery Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35. Terminated |
GDW | None listed |
| Dec 17, 2003 | Ethicon Endo-Surgery Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35. Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.