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)
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Top companies in GDW

DateFirm and productCodeLinked 510(k)
Jun 21, 2012Covidien LP
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and cr
Terminated
GDWK855047
Jun 21, 2012Covidien LP
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and c
Terminated
GDWK855047
Jun 21, 2012Covidien LP
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and c
Terminated
GDWK855047
Jun 21, 2012Covidien LP
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and c
Terminated
GDWK855047
Jun 21, 2012Covidien LP
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and cr
Terminated
GDWK855047
May 18, 2012Ethicon 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
GDWK051002
K070887
Mar 19, 2012Covidien LP
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatri
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic su
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery f
Terminated
GDWNone listed
Feb 13, 2012Covidien LP
DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic sur
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery f
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic su
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 45 4.8MM STRAIGHT SULU Product Code: DUET4548 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery f
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic sur
Terminated
GDWK080898
Feb 13, 2012Covidien LP
DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal, gynecologic and pediatric surgery fo
Terminated
GDWK080898
Sep 12, 2011Ethicon 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
GDWK020779
K061156 +1
Sep 8, 2011Covidien LP
DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appli
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appli
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4548A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4548 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appl
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535A The ENDO GIA Universal Staplers with DUET TRS Loading Unit have
Terminated
GDWK080898
Sep 8, 2011Covidien LP
DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have appl
Terminated
GDWK080898
Feb 18, 2011Ethicon, Inc.
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures
Terminated
GDWK093845
Nov 15, 2010Ethicon 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
GDWK020779
K070887
Mar 16, 2010Covidien LP
Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
Terminated
GDWK090470
K963999
Nov 23, 2009Surgical Devices/Covidien
Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, product code PWCD.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Device Sterilization Tray, product code T300.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion
Terminated
GDWK091215
Nov 23, 2009Surgical Devices/Covidien
Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscop
Terminated
GDWK081826
Nov 23, 2009Surgical Devices/Covidien
Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC.
Terminated
GDWK083527
Nov 23, 2009Surgical Devices/Covidien
Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF.
Terminated
GDWK073001
Nov 23, 2009Surgical Devices/Covidien
Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Gree
Terminated
GDWK071708
Nov 23, 2009Surgical Devices/Covidien
Program Memory Card, product code MCV1A.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Sterile Sheath, product code SS01.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Console, product code PC100; Power Console System, product code PC100S; Power Console Reconditioned, product code PC100RC.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stapler 29 mm Digital Loading Unit, product code PCS29.
Terminated
GDWK040024
Nov 23, 2009Surgical Devices/Covidien
Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear Cutter Reload, 45 mm Green, product code PLCR45G; Reusable Endoscopic Linear Cutter, 60 mm, product code PLC60; End
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power E
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75
Terminated
GDWK040720
Nov 23, 2009Surgical Devices/Covidien
FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product
Terminated
GDWK021249
Nov 23, 2009Surgical Devices/Covidien
Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, pro
Terminated
GDWK020719
Nov 23, 2009Surgical Devices/Covidien
Remote Control Unit with Wire, product code RCW100.
Terminated
GDWK020343
Nov 23, 2009Surgical Devices/Covidien
Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digit
Terminated
GDWK021701
Nov 23, 2009Surgical Devices/Covidien
Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular
Terminated
GDWK032701
Nov 23, 2009Surgical Devices/Covidien
SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, produc
Terminated
GDWK003277
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box, Item Number: 0113061
Terminated
GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Laproscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059
Terminated
GDWNone listed

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