510(k) K061156 ยท GDW Staple, Implantable
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 3, 2006 |
| Received | Apr 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2011 | Ethicon Endo-Surgery Inc ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969
The ETS Compact- Terminated |
GDW | None listed |
| Feb 15, 2011 | Ethicon Endo-Surgery Inc FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays.
I Terminated |
LRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.