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

Decided510(k)Device and applicantCode
Nov 12, 2009K093253AMID STAPLER
Safestitch, LLC
GDW
Sep 15, 2009K092577ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
Ethicon Endo-Surgery, LLC
GDW
Jul 16, 2009K091900ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
Covidien Lp, Formerly Registered AS United States
GDW
Jun 10, 2009K090821CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
Frankenman International Limited
GDW
Jun 1, 2009K091322CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
Ethicon Endo-Surgery, Inc.
GDW
May 18, 2009K091215INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
Power Medical Interventions, Inc.
GDW
Apr 10, 2009K083519AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
Covidien Lp, Formerly Registered AS United States
GDW
Feb 6, 2009K090159INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
Incisive Surgical, Inc.
GDW
Feb 4, 2009K083781EEA HEMORRHOID STAPLER & ACCESSORIES
Surgical Devices, A Global Business Unit Covidien
GDW
Jan 2, 2009K082396DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
C.R. Bard, Inc.
GDW
Dec 18, 2008K083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
Power Medical Interventions, Inc.
GDW
Aug 28, 2008K071023REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
Reach Surgical, Inc.
GDW
Jul 25, 2008K081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
Power Medical Interventions, Inc.
GDW
Jul 3, 2008K080972ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
Ethicon Endo-Sugery, LLC
GDW
Jun 26, 2008K081146ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
Ethicon Endo-Surgery, LLC
GDW
May 21, 2008K080839ECHELON GRAY CARTRIDGE, MODEL ERC45M
Ethicon Endo-Surgery, LLC
GDW
May 5, 2008K080898AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
Tyco Healthcare Group LP
GDW
Dec 18, 2007K073001IDRIVES, IDRIVEC, IDRIVEF
Power Medical Interventions, Inc.
GDW
Dec 7, 2007K073148IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
Power Medical Interventions, Inc.
GDW
Sep 28, 2007K071920AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
United States Surgical, A Division of Tyco Healthc
GDW
Sep 27, 2007K071708I45, I45S, I60, AND I60S
Power Medical Interventions, Inc.
GDW
May 25, 2007K070887ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
Ethicon Endo-Surgery, LLC
GDW
May 16, 2007K071061ABSORBATACK AND APPLICATOR
Sorbx, LLC
GDW
Feb 26, 2007K062869CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
Ethicon Endo-Surgery, LLC
GDW
Jan 12, 2007K063746POWER EXTENDERS MODEL# PEC200, PES200,PES200S
Power Medical Interventions, Inc.
GDW
Nov 2, 2006K063075NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
Power Medical Interventions, Inc.
GDW
Oct 23, 2006K062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
United States Surgical, A Division of Tyco Healthc
GDW
Sep 1, 2006K061649POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
Power Medical Interventions, Inc.
GDW
Jul 26, 2006K061784INSORB ABSORBABLE STAPLE, MODEL 1020
Incisive Surgical, Inc.
GDW
Jul 3, 2006K061156ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
Ethicon Endo-Surgery, Inc.
GDW
Jul 3, 2006K060494EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
Medchannel, LLC
GDW
May 31, 2006K061095AUTO SUTUR ENDO GIA STAPLERS
United States Surgical, A Division of Tyco Healthc
GDW
Jan 30, 2006K053631CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
Ethicon Endo-Surgery, Inc.
GDW
Nov 7, 2005K052910POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
Power Medical Interventions, Inc.
GDW
Sep 29, 2005K052415POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
Power Medical Interventions, Inc.
GDW
Aug 30, 2005K051301PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
Ethicon Endo-Surgery, Inc.
GDW
Aug 11, 2005K051848SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
Davol Inc., Sub. C. R. Bard, Inc.
GDW
May 25, 2005K050610SALUTE FIXATION SYSTEM
Davol Inc., Sub. C. R. Bard, Inc.
GDW
May 17, 2005K051002ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
Ethicon Endo-Surgery, Inc.
GDW
Oct 19, 2004K042492HAND STC, MODEL 60MM
Niti Medical Technologies , Ltd., IL
GDW
Jul 27, 2004K041159JMS ABSORBABLE ANCHOR AND APPLICATOR
Jms, Inc.
GDW
Jun 15, 2004K041331BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
Biopsy Sciences, LLC
GDW
Jun 3, 2004K041201ULTRACLIP II MR
Inrad
GDW
Jun 3, 2004K040720SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
Power Medical Interventions, Inc.
GDW
Mar 25, 2004K040109HEMORRHAGE OCCLUDER PIN
Tools For Surgery, LLC
GDW
Mar 24, 2004K040398SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
Power Medical Interventions, Inc.
GDW
Feb 4, 2004K040038CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G
Ethicon Endo-Surgery, Inc.
GDW
Feb 4, 2004K040024SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
Power Medical Interventions, Inc.
GDW
Dec 18, 2003K032973REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
Vanguard Medical Concepts, Inc.
GDW
Dec 16, 2003K033602INSORB ABSORBABLE STAPLE, MODEL SP-B20
Incisive Surgical, Inc.
GDW

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