510(k) K070887 ยท GDW Staple, Implantable
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, May 25, 2007 |
| Received | Mar 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2012 | Ethicon Endo-Surgery Inc The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use Terminated |
GDW | None listed |
| 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 ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45.
Intended for transection, resection, and/or creation of a Terminated |
GEI | None listed |
| Nov 15, 2010 | Ethicon Endo-Surgery Inc ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.