ClearanceBrief
Panels › General, Plastic Surgery › Product code GDW · Class 2

Staple, Implantable

Regulation 878.4750

4510(k)s in 12 months (284 all time)
0recalls in 12 months (225 all time)
196recalls that name a 510(k)
Get daily alerts for GDWSample briefCSV

Top companies in GDW

Company510(k)sRecalls
Covidien2769
Ethicon Endo-Surgery4440
COVIDIEN MEDTRONIC054
United States Surgical, A Division of Tyco Healthc280
Power Medical Interventions, Inc.221
Surgical Devices/Covidien021
Davol Inc., Sub. C. R. Bard, Inc.29
ETHICON, Inc.101
C.R. Bard, Inc.100
United States Surgical09
DateFirm and productCodeLinked 510(k)
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035
Terminated		 GDWK050610
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058
Terminated		 GDWK050610
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished)
Terminated		 GDWK050610
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
Terminated		 GDWK050610
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished)
Terminated		 GDWK050610
Jul 24, 2007Power Medical Interventions, Inc
Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
Terminated		 GDWK052415
Jun 28, 2007Ethicon Endo-Surgery Inc
Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope
Terminated		 GDWK051301
Feb 1, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)
Terminated		 GDWK050610
Feb 1, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished)
Terminated		 GDWK050610
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 No Knife Linear Stapler (NK45G).
Terminated		 GDWK020779
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 Endoscopic Linear Cutter (ET45G).
Terminated		 GDWK020779
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 Endoscopic Linear Cutter (ET45B).
Terminated		 GDWK020779
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 Endoscopic Linear Cutter (EZ45G).
Terminated		 GDWK020779
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 No Knife Linear Stapler (NK45B).
Terminated		 GDWK020779
Feb 1, 2005Ethicon Endo-Surgery
Endopath EZ45 Endoscopic Linear Cutter (EZ45B)
Terminated		 GDWK020779
Jul 20, 2004United States Surgical
Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA9035S
Terminated		 GDWNone listed
Jul 20, 2004United States Surgical
Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA6048S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA6035S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA4548S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 30 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA30348S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series Ref: TA3035S
Terminated		 GDWK013860
Jul 20, 2004United States Surgical
Auto Suture TA 30 Reloadable Staplers, Single Patient Use Ref TA30V3S, V3 (2.5mm) DST Series
Terminated		 GDWK013860
Dec 17, 2003Ethicon Endo-Surgery
Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
Terminated		 GDWK020779
K961390

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.