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

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
Decided510(k)Device and applicantCode
Jan 14, 2014K133499SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
Suzhou Beinuo Medical Equipment Co. , Ltd.
GDW
Jan 13, 2014K132669PROXIFAST ABSORBABLE STAPLE
Surgimatix, Inc.
GDW
Jan 8, 2014K133762ENDO GIA(TM) EXTRA LONG ADAPTER
Covidien, LLC
GDW
Jan 7, 2014K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
Cardica, Inc.
GDW
Dec 13, 2013K130738ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
Nanjing Maidixin Medical Device Co., Ltd., CN
GDW
Dec 2, 2013K132134OPTIFIX ABSORBABLE FIXATION SYSTEM
C.R. Bard, Inc.
GDW
Oct 23, 2013K132493ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Covidien, LLC
GDW
Oct 18, 2013K131663ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
Ethicon Endo-Surgery, LLC
GDW
Jul 12, 2013K131637ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
Rotation Medical, Inc.
GDW
Jul 5, 2013K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
Changzhou Sinolinks Medical Innovation Co., Ltd., CN
GDW
Jul 1, 2013K131705ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Jun 11, 2013K131303DISPOSABLE CIRCULAR STAPLER
Changzhou City Zhiye Medical Devices Institute Co.
GDW
Apr 18, 2013K130717ENDO GIA RELOAD
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Mar 29, 2013K130653ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU
Ethicon Endo-Surgery, LLC
GDW
Feb 5, 2013K123114ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
ETHICON, Inc.
GDW
Feb 5, 2013K122781RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Jan 22, 2013K123718PERMASORB DISPOSABLE FIXATION DEVICE
C.R. Bard, Inc.
GDW
Dec 18, 2012K123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Oct 23, 2012K123109ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
Covidien
GDW
Jul 25, 2012K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Jul 16, 2012K121600ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
Ethicon Endo-Surgery, LLC
GDW
Jul 16, 2012K121474DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
Changzhou Kangdi Medical Stapler Co., Ltd.
GDW
May 23, 2012K120179REACH SURGICAL STAPLERS
Reach Surgical, Inc., CN
GDW
Mar 16, 2012K120373INSORB ABSORBALBE STAPLE
Incisive Surgical, Inc.
GDW
Feb 29, 2012K120258DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Feb 10, 2012K120268AMID STAPLER
Safestich Medical, LLC
GDW
Dec 19, 2011K112056ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
Ethicon Endo-Surgery, LLC
GDW
Oct 25, 2011K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Aug 3, 2011K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
Ethicon Endo-Surgery, Inc.
GDW
Jun 8, 2011K111111ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
Ethicon Endo-Surgery, LLC
GDW
Jun 8, 2011K110728IMESH TACKER
Easylap , Ltd.
GDW
May 24, 2011K111153SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
C.R. Bard, Inc.
GDW
May 18, 2011K111064TIGERPAW SYSTEM II
Laax, Inc.
GDW
Apr 8, 2011K103672REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
Ethicon Endo-Surgery, LLC
GDW
Mar 25, 2011K110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
Ethicon Endo-Surgery, Inc.
GDW
Feb 10, 2011K110049REUSABLE LINEAR STAPLER HANDLE
Ethicon Endo-Surgery, LLC
GDW
Jan 11, 2011K103470PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., CN
GDW
Nov 22, 2010K103263ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
Covidien, Formerly US Surgical A Divison of Tyco H
GDW
Oct 29, 2010K101961TIGERPAW SYSTEM
Laax, Inc.
GDW
Oct 13, 2010K102325IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
Covidien, LLC, Formerly Registered AS Tyco Healthca
GDW
Oct 7, 2010K102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
Ethicon Endo-Surgery, Inc.
GDW
Sep 15, 2010K102291COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Covidien
GDW
Jun 29, 2010K101378FRANKENMAN SURGICAL STAPLERS
Suzhou Frankenman Medical Equipment Co., Ltd.
GDW
Jun 14, 2010K101444AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
Surgical Devices, A Global Business Unit Tyco
GDW
Apr 30, 2010K100723DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
Changzhou Kangdi Medical Stapler Co., Ltd.
GDW
Apr 7, 2010K093845ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
ETHICON, Inc.
GDW
Mar 1, 2010K100386DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
Changzhou Waston Medical Appliance Co., Ltd., CN
GDW
Dec 18, 2009K092483BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
C.R. Bard, Inc.
GDW
Nov 12, 2009K093410AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
Surgical Devices, A Divsion of Tyco Healthcare
GDW
Nov 12, 2009K093402AUTOSUTURE EEA ORVIL
Surgical Devices, A Global Business Unit Tyco
GDW

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