510(k) K020779 ยท GDW Staple, Implantable
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 5, 2002 |
| Received | Mar 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020779
| 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 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 |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | None listed |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS Endoscopic Linear Cutter, TSW35.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | None listed |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | None listed |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S.
Utilized during general, gynecologic, urologic, and thoracic surgery for Terminated |
FZT | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 Endoscopic Linear Cutter (EZ45B) Terminated |
GDW | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 No Knife Linear Stapler (NK45B). Terminated |
GDW | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 Endoscopic Linear Cutter (EZ45G). Terminated |
GDW | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 Endoscopic Linear Cutter (ET45B). Terminated |
GDW | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 Endoscopic Linear Cutter (ET45G). Terminated |
GDW | None listed |
| Feb 1, 2005 | Ethicon Endo-Surgery Endopath EZ45 No Knife Linear Stapler (NK45G). Terminated |
GDW | None listed |
| 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 |
| Jul 8, 2003 | Ethicon Endo-Surgery Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm. Terminated |
MDM | None listed |
| Jul 8, 2003 | Ethicon Endo-Surgery Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm. Terminated |
MDM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.