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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 2000-12-21

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33

Applicant Powermed, Inc.

K number K003277

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GDW 2000-12-08

VASCULAR CLOSURE DEVICE

Applicant Std Mfg., Inc.

K number K003169

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GDW 2000-12-08

AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K001895

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GDW 2000-03-27

GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007

Applicant Senorx, Inc.

K number K000060

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GDW 2000-03-07

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM

Applicant Std Mfg., Inc.

K number K000608

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GDW 2000-02-04

ULTRACLIP TISSUE MARKER

Applicant Inrad

K number K993785

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GDW 1999-05-17

PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

Applicant Ethicon Endo-Surgery, Inc.

K number K991030

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GDW 1999-03-01

FIXATION SYSTEM

Applicant General Surgical Innovations

K number K983318

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GDW 1999-02-10

AUTO SUTURE SITE MARKER CLIP

Applicant United States Surgical, A Division of Tyco Healthc

K number K983400

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GDW 1998-12-18

PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS

Applicant Ethicon Endo-Surgery, Inc.

K number K983536

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GDW 1998-04-09

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

Applicant Urohealth Systems, Inc.

K number K980617

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GDW 1997-09-11

MICROMARK CLIP

Applicant Biopsys Medical, Inc.

K number K970817

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GDW 1996-10-07

SURGICAL STAPLE MARKER DEVICE (MODIFY)

Applicant Biopsys Medical, Inc.

K number K963015

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GDW 1995-10-03

AUTO SUTURE* MODIFIED LINEAR STAPLER**

Applicant United States Surgical, A Division of Tyco Healthc

K number K952239

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GDW 1995-03-15

SURGICAL STAPLE MARKER

Applicant Biopsys Medical, Inc.

K number K950006

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GDW 1994-08-24

SURGICAL STAPLE

Applicant United States Surgical, A Division of Tyco Healthc

K number K942606

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GDW 1993-10-12

STRYKER STAPLER SYSTEM

Applicant Stryker Endoscopy

K number K931103

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GDW 1993-07-08

DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING

Applicant American Cyanamid Co.

K number K931056

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GDW 1992-08-06

HEM-O-LOK -- MODIFICATION

Applicant Linvatec Corp.

K number K922186

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GDW 1992-08-06

ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER

Applicant ETHICON, Inc.

K number K920752

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GDW 1992-07-16

3M PRECISE BRAND INTERNAL SURGICAL STAPLES

Applicant 3M Health Care, Ltd.

K number K921051

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GDW 1992-03-19

PROXIMATE ABSORBABLE STAPLES

Applicant ETHICON, Inc.

K number K915693

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GDW 1992-01-31

AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE

Applicant United States Surgical, A Division of Tyco Healthc

K number K915489

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GDW 1991-10-17

AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES

Applicant United States Surgical, A Division of Tyco Healthc

K number K914130

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GDW 1991-10-17

AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K913832

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GDW 1991-10-17

AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K913802

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GDW 1991-09-25

AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K913211

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GDW 1991-09-06

DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING

Applicant Davis & Geck, Inc.

K number K913411

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GDW 1991-09-06

IMPLANTABLE METAL STAPLES

Applicant ETHICON, Inc.

K number K913139

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GDW 1991-07-25

PRECISE BARND PI DISPOSABLE SURGICAL STAPLES

Applicant 3M Medical Products Group

K number K911252

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GDW 1991-04-01

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X

Applicant 3M Medical Products Group

K number K910897

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GDW 1991-02-11

AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K910192

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GDW 1991-01-31

AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K905106

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GDW 1990-02-27

MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*

Applicant United States Surgical, A Division of Tyco Healthc

K number K900129

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GDW 1990-02-09

MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS

Applicant United States Surgical, A Division of Tyco Healthc

K number K900055

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GDW 1990-02-09

MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K900043

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GDW 1989-04-28

AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K892233

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GDW 1989-04-19

TITANIUM STAPLES

Applicant ETHICON, Inc.

K number K890841

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GDW 1989-03-17

AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*

Applicant United States Surgical, A Division of Tyco Healthc

K number K890270

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GDW 1989-02-23

HEMORRHAGE OCCLUDOR

Applicant Surgeon Surgical Instrumentation, Inc.

K number K890447

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GDW 1989-02-03

PRECISE ILA AND ILAN SURGICAL STAPLES

Applicant 3M Company

K number K885222

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GDW 1988-05-04

BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING

Applicant Davis & Geck, Inc.

K number K881484

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GDW 1988-01-06

RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT

Applicant Deknatel, Inc.

K number K873748

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GDW 1986-11-05

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)

Applicant Cardio Thoracic Systems

K number K864146

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GDW 1986-01-14

AUTO SUTURE TITANIUM SURGICAL STAPLES

Applicant United States Surgical, A Division of Tyco Healthc

K number K855047

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GDW 1985-04-25

PI-PNEUMO INTESTINAL STAPLING CARTRIDGE

Applicant Surgeons Choice, Inc.

K number K851122

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GDW 1984-11-05

SURGEONS CHOICE PI VASCULAR STAPLING

Applicant Surgeons Choice, Inc.

K number K843399

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GDW 1984-10-31

AUTO SUTURE POLY GIA SURGICAL STAPLER

Applicant United States Surgical, A Division of Tyco Healthc

K number K843603

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GDW 1984-09-17

DISPOSABLE LINEAR CUTTER

Applicant ETHICON, Inc.

K number K843034

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GDW 1984-01-25

AMER. V. MUELLER SURG. STAPLES ILA

Applicant American Heyer Schulte

K number K833698

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GDW 1983-12-29

AMER. V. MUELLER SURGICALSTAPLES-CARTR

Applicant American Heyer Schulte

K number K833704

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GDW 1983-06-15

APPOSE SKIN STAPLER & REMOVER

Applicant American Cyanamid Co.

K number K823552

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GDW 1983-04-12

AUTO SUTURE TA DISPOS-STAPLE CART

Applicant United States Surgical, A Division of Tyco Healthc

K number K830199

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GDW 1982-09-21

DISPOSABLE LINEAR STAPLER (LSF)

Applicant ETHICON, Inc.

K number K822345

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GDW 1982-08-03

DISPOSABLE LINEAR STAPLER-(LSR)

Applicant ETHICON, Inc.

K number K821994

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GDW 1981-03-20

AUTOMATIC HEMOCLIP APPLIER, 527700

Applicant Edward Weck, Inc.

K number K810324

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GDW 1980-06-20

PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.

Applicant ETHICON, Inc.

K number K801154

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GDW 1978-06-22

AUTO SUTURE DISPOSABLE STAPLING INSTRU.

Applicant United States Surgical, A Division of Tyco Healthc

K number K780695

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GDW 1978-05-16

MICROCLIP, WILLIAMS

Applicant Richard'S Medical Equip., Inc.

K number K780586

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GDW 1977-10-18

DISP. LOADING UNIT, AUTO, SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K771178

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GDW 1976-12-30

COVENTRY STAPLE

Applicant Depuy, Inc.

K number K761064

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