510(k) K111111 ยท GDW Staple, Implantable
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 8, 2011 |
| Received | Apr 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2017 | Ethicon Endo-Surgery Inc Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM Terminated |
GDW | None listed |
| Oct 20, 2016 | Ethicon Endo-Surgery Inc Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM.
The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for tr Terminated |
GDW | None listed |
| Oct 20, 2016 | Ethicon Endo-Surgery Inc Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM
The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery f Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.