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Staple, Implantable

FDA product code GDW · 261 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4750
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-30 – 2026-09-25

GDW 2012-03-16

INSORB ABSORBALBE STAPLE

Applicant Incisive Surgical, Inc.

K number K120373

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GDW 2012-02-29

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS

Applicant Covidien, Formerly US Surgical A Divison of Tyco H

K number K120258

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GDW 2012-02-10

AMID STAPLER

Applicant Safestich Medical, LLC

K number K120268

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GDW 2011-12-19

ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL

Applicant Ethicon Endo-Surgery, LLC

K number K112056

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GDW 2011-10-25

ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS

Applicant Covidien, Formerly US Surgical A Divison of Tyco H

K number K111825

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GDW 2011-08-03

VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS

Applicant Ethicon Endo-Surgery, Inc.

K number K111195

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GDW 2011-06-08

ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO

Applicant Ethicon Endo-Surgery, LLC

K number K111111

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GDW 2011-06-08

IMESH TACKER

Applicant Easylap , Ltd.

K number K110728

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GDW 2011-05-24

SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM

Applicant C.R. Bard, Inc.

K number K111153

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GDW 2011-05-18

TIGERPAW SYSTEM II

Applicant Laax, Inc.

K number K111064

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GDW 2011-04-08

REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

Applicant Ethicon Endo-Surgery, LLC

K number K103672

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GDW 2011-03-25

ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER

Applicant Ethicon Endo-Surgery, Inc.

K number K110385

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GDW 2011-02-10

REUSABLE LINEAR STAPLER HANDLE

Applicant Ethicon Endo-Surgery, LLC

K number K110049

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GDW 2011-01-11

PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP

Applicant B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K number K103470

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GDW 2010-11-22

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

Applicant Covidien, Formerly US Surgical A Divison of Tyco H

K number K103263

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GDW 2010-10-29

TIGERPAW SYSTEM

Applicant Laax, Inc.

K number K101961

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GDW 2010-10-13

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)

Applicant Covidien, LLC, Formerly Registered AS Tyco Healthca

K number K102325

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GDW 2010-10-07

ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER

Applicant Ethicon Endo-Surgery, Inc.

K number K102632

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GDW 2010-09-15

COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

Applicant Covidien

K number K102291

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GDW 2010-06-29

FRANKENMAN SURGICAL STAPLERS

Applicant Suzhou Frankenman Medical Equipment Co., Ltd.

K number K101378

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GDW 2010-06-14

AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY

Applicant Surgical Devices, A Global Business Unit Tyco

K number K101444

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GDW 2010-04-30

DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5

Applicant Changzhou Kangdi Medical Stapler Co., Ltd.

K number K100723

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GDW 2010-04-07

ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25

Applicant ETHICON, Inc.

K number K093845

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GDW 2010-03-01

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32

Applicant Changzhou Waston Medical Appliance Co., Ltd.

K number K100386

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GDW 2009-12-18

BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018

Applicant C.R. Bard, Inc.

K number K092483

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GDW 2009-11-12

AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY

Applicant Surgical Devices, A Divsion of Tyco Healthcare

K number K093410

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GDW 2009-11-12

AUTOSUTURE EEA ORVIL

Applicant Surgical Devices, A Global Business Unit Tyco

K number K093402

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GDW 2009-11-12

AMID STAPLER

Applicant Safestitch, LLC

K number K093253

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GDW 2009-09-15

ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)

Applicant Ethicon Endo-Surgery, LLC

K number K092577

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GDW 2009-07-16

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

Applicant Covidien Lp, Formerly Registered AS United States

K number K091900

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GDW 2009-06-10

CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L

Applicant Frankenman International Limited

K number K090821

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GDW 2009-06-01

CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G

Applicant Ethicon Endo-Surgery, Inc.

K number K091322

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GDW 2009-05-18

INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT

Applicant Power Medical Interventions, Inc.

K number K091215

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GDW 2009-04-10

AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS

Applicant Covidien Lp, Formerly Registered AS United States

K number K083519

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GDW 2009-02-06

INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES

Applicant Incisive Surgical, Inc.

K number K090159

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GDW 2009-02-04

EEA HEMORRHOID STAPLER & ACCESSORIES

Applicant Surgical Devices, A Global Business Unit Covidien

K number K083781

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GDW 2009-01-02

DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087

Applicant C.R. Bard, Inc.

K number K082396

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GDW 2008-12-18

INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS

Applicant Power Medical Interventions, Inc.

K number K083527

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GDW 2008-08-28

REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C

Applicant Reach Surgical, Inc.

K number K071023

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GDW 2008-07-25

INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V

Applicant Power Medical Interventions, Inc.

K number K081826

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GDW 2008-07-03

ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

Applicant Ethicon Endo-Sugery, LLC

K number K080972

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GDW 2008-06-26

ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)

Applicant Ethicon Endo-Surgery, LLC

K number K081146

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GDW 2008-05-21

ECHELON GRAY CARTRIDGE, MODEL ERC45M

Applicant Ethicon Endo-Surgery, LLC

K number K080839

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GDW 2008-05-05

AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT

Applicant Tyco Healthcare Group LP

K number K080898

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GDW 2007-12-18

IDRIVES, IDRIVEC, IDRIVEF

Applicant Power Medical Interventions, Inc.

K number K073001

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GDW 2007-12-07

IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS

Applicant Power Medical Interventions, Inc.

K number K073148

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GDW 2007-09-28

AUTOSUTURE ABSORBABLE TACK AND APPLICATOR

Applicant United States Surgical, A Division of Tyco Healthc

K number K071920

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GDW 2007-09-27

I45, I45S, I60, AND I60S

Applicant Power Medical Interventions, Inc.

K number K071708

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GDW 2007-05-25

ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)

Applicant Ethicon Endo-Surgery, LLC

K number K070887

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GDW 2007-05-16

ABSORBATACK AND APPLICATOR

Applicant Sorbx, LLC

K number K071061

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GDW 2007-02-26

CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G

Applicant Ethicon Endo-Surgery, LLC

K number K062869

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GDW 2007-01-12

POWER EXTENDERS MODEL# PEC200, PES200,PES200S

Applicant Power Medical Interventions, Inc.

K number K063746

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GDW 2006-11-02

NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS

Applicant Power Medical Interventions, Inc.

K number K063075

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GDW 2006-10-23

AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS

Applicant United States Surgical, A Division of Tyco Healthc

K number K062850

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GDW 2006-09-01

POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH

Applicant Power Medical Interventions, Inc.

K number K061649

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GDW 2006-07-26

INSORB ABSORBABLE STAPLE, MODEL 1020

Applicant Incisive Surgical, Inc.

K number K061784

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GDW 2006-07-03

ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS

Applicant Ethicon Endo-Surgery, Inc.

K number K061156

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GDW 2006-07-03

EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM

Applicant Medchannel, LLC

K number K060494

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GDW 2006-05-31

AUTO SUTUR ENDO GIA STAPLERS

Applicant United States Surgical, A Division of Tyco Healthc

K number K061095

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GDW 2006-01-30

CONTOUR TRANSTAR CURVED CUTTER STAPLER SET

Applicant Ethicon Endo-Surgery, Inc.

K number K053631

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GDW 2005-11-07

POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS

Applicant Power Medical Interventions, Inc.

K number K052910

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GDW 2005-09-29

POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS

Applicant Power Medical Interventions, Inc.

K number K052415

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GDW 2005-08-30

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

Applicant Ethicon Endo-Surgery, Inc.

K number K051301

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GDW 2005-08-11

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

Applicant Davol Inc., Sub. C. R. Bard, Inc.

K number K051848

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GDW 2005-05-25

SALUTE FIXATION SYSTEM

Applicant Davol Inc., Sub. C. R. Bard, Inc.

K number K050610

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GDW 2005-05-17

ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER

Applicant Ethicon Endo-Surgery, Inc.

K number K051002

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GDW 2004-10-19

HAND STC, MODEL 60MM

Applicant Niti Medical Technologies , Ltd.

K number K042492

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GDW 2004-07-27

JMS ABSORBABLE ANCHOR AND APPLICATOR

Applicant Jms, Inc.

K number K041159

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GDW 2004-06-15

BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

Applicant Biopsy Sciences, LLC

K number K041331

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GDW 2004-06-03

ULTRACLIP II MR

Applicant Inrad

K number K041201

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GDW 2004-06-03

SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM

Applicant Power Medical Interventions, Inc.

K number K040720

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GDW 2004-03-25

HEMORRHAGE OCCLUDER PIN

Applicant Tools For Surgery, LLC

K number K040109

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GDW 2004-03-24

SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS

Applicant Power Medical Interventions, Inc.

K number K040398

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GDW 2004-02-04

CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G

Applicant Ethicon Endo-Surgery, Inc.

K number K040038

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GDW 2004-02-04

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29

Applicant Power Medical Interventions, Inc.

K number K040024

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GDW 2003-12-18

REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS

Applicant Vanguard Medical Concepts, Inc.

K number K032973

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GDW 2003-12-16

INSORB ABSORBABLE STAPLE, MODEL SP-B20

Applicant Incisive Surgical, Inc.

K number K033602

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GDW 2003-12-01

AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT

Applicant United States Surgical, A Division of Tyco Healthc

K number K032696

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GDW 2003-09-30

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)

Applicant Power Medical Interventions, Inc.

K number K032701

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GDW 2003-08-21

BIOMARC TISSUE MARKER

Applicant Carbon Medical Technologies, Inc.

K number K032347

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GDW 2003-05-15

PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01

Applicant Ethicon Endo-Surgery, Inc.

K number K030925

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GDW 2003-04-22

INSORB ABSORBABLE STAPLES, MODEL SP-B20

Applicant Incisive Surgical, Inc.

K number K024117

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GDW 2003-03-31

SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS

Applicant Power Medical Interventions, Inc.

K number K030653

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GDW 2003-03-20

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03

Applicant Ethicon Endo-Surgery, Inc.

K number K030411

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GDW 2003-03-14

AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K024275

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GDW 2003-02-03

HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247

Applicant Marina Medical Instruments, Inc.

K number K023725

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GDW 2002-12-09

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V

Applicant Power Medical Interventions, Inc.

K number K022313

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GDW 2002-11-19

AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K020804

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GDW 2002-06-21

SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60

Applicant Power Medical Interventions, Inc.

K number K021701

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GDW 2002-06-05

PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS

Applicant Ethicon Endo-Surgery, Inc.

K number K020779

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GDW 2002-05-15

SURGASSIST FLEXSHAFT 2, MODEL FS2 14

Applicant Power Medical Interventions, Inc.

K number K021249

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GDW 2002-05-10

SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES

Applicant Power Medical Interventions, Inc.

K number K020719

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GDW 2002-04-10

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL

Applicant Power Medical Interventions, Inc.

K number K020343

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GDW 2002-03-08

SALUTE, MODEL 3022

Applicant Onux Medical, Inc.

K number K014286

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GDW 2002-02-11

ENDOANCHOR AND OPENANCHOR

Applicant Ethicon Endo-Surgery, Inc.

K number K013749

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GDW 2001-12-19

AUTO SUTURE SURGICAL STAPLES

Applicant United States Surgical, A Division of Tyco Healthc

K number K013860

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GDW 2001-10-26

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45

Applicant Power Medical Interventions, Inc.

K number K012809

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GDW 2001-08-23

MODIFICATION TO VASCULAR CLOSURE DEVICE

Applicant Std Mfg., Inc.

K number K012362

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GDW 2001-05-03

TISSUE MARKER

Applicant Advanced Uroscience, Inc.

K number K001807

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GDW 2001-02-13

SALUTE

Applicant Onux Medical, Inc.

K number K003522

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