Atlas FDA

PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS

FDA 510(k) clearance K020779 · decided 2002-06-05

Clearance details

K-number
K020779
Device name
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
Applicant
Ethicon Endo-Surgery, Inc.
Decision
Substantially Equivalent
Date received
2002-03-11
Decision date
2002-06-05
Days to decision
86 days
Clearance type
Traditional
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Cincinnati, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CT recall (Z-3187-2011)Ethicon Endo-Surgery Inc2011-09-12
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; recall (Z-1068-2011)Ethicon Endo-Surgery Inc2011-02-15
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by recall (Z-0361-2011)Ethicon Endo-Surgery Inc2010-11-15
ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, uro recall (Z-2161-2008)Ethicon Endo-Surgery Inc2008-08-25
ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologi recall (Z-2162-2008)Ethicon Endo-Surgery Inc2008-08-25
ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, recall (Z-2163-2008)Ethicon Endo-Surgery Inc2008-08-25
FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58 recall (Z-2164-2008)Ethicon Endo-Surgery Inc2008-08-25
Endopath EZ45 Endoscopic Linear Cutter (EZ45B) recall (Z-0457-05)Ethicon Endo-Surgery2005-02-01
Endopath EZ45 No Knife Linear Stapler (NK45B). recall (Z-0458-05)Ethicon Endo-Surgery2005-02-01
Endopath EZ45 Endoscopic Linear Cutter (EZ45G). recall (Z-0459-05)Ethicon Endo-Surgery2005-02-01
Endopath EZ45 Endoscopic Linear Cutter (ET45B). recall (Z-0460-05)Ethicon Endo-Surgery2005-02-01
Endopath EZ45 Endoscopic Linear Cutter (ET45G). recall (Z-0461-05)Ethicon Endo-Surgery2005-02-01
Endopath EZ45 No Knife Linear Stapler (NK45G). recall (Z-0462-05)Ethicon Endo-Surgery2005-02-01
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standar recall (Z-0212-04)Ethicon Endo-Surgery2003-12-17
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascula recall (Z-0213-04)Ethicon Endo-Surgery2003-12-17
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples wi recall (Z-0985-03)Ethicon Endo-Surgery2003-07-08
Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples wi recall (Z-0986-03)Ethicon Endo-Surgery2003-07-08