Suture, Nonabsorbable, Synthetic, Polyethylene

FDA product code GAT · 165 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5000
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1993-12-13 – 2026-08-22

GAT 2007-04-02

FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE

Applicant Teleflexmedical, Inc.

K number K070673

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GAT 2007-02-09

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE

Applicant Teleflex Medical

K number K063778

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GAT 2006-12-06

G-PROX ENDOSCOPIC GRASPER

Applicant Usgi Medical

K number K061276

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GAT 2006-12-04

TUFFLEX POLYESTER SUTURE

Applicant Axya Medical, Inc.

K number K063194

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GAT 2006-10-11

CARDIOFLON, CARDIOXYL

Applicant Peters Surgical

K number K060163

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GAT 2006-09-01

XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS

Applicant Anulex Technologies, Inc.

K number K062307

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GAT 2006-09-01

AXYAFLEX POLYESTER SUTURE

Applicant Axya Medical, Inc.

K number K060165

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GAT 2006-08-09

TENOLIG

Applicant Fournitures Hospitalieres Industrie

K number K060367

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GAT 2006-07-05

ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB

Applicant Anulex Technologies, Inc.

K number K061386

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GAT 2006-06-02

LARIAT LOOP APPLICATOR

Applicant Sentreheart

K number K060721

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GAT 2006-03-16

ALLOFIX ANCHOR

Applicant Musculoskeletal Transplant Foundation

K number K053339

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GAT 2005-12-05

MANI NEEDLE & SUTURE PACK

Applicant Mani, Inc.

K number K050150

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GAT 2005-10-21

SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE

Applicant Smith & Nephew, Inc.

K number K052652

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GAT 2005-06-02

NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE

Applicant Sutures India Private Limited

K number K041512

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GAT 2004-12-23

MTF ALLOGRAFT ANCHOR

Applicant Musculoskeletal Transplant Foundation

K number K042038

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GAT 2004-12-10

ARTHREX SUTURE GRAFTING KIT

Applicant Arthrex, Inc.

K number K041553

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GAT 2004-12-01

UNIESTER C

Applicant United Medical Industries Co. , Ltd.

K number K042286

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GAT 2004-10-19

OPUS SPEEDSTITCH SUTURE DEVICE

Applicant Opus Medical, Inc.

K number K042031

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GAT 2004-09-17

ORTHOFIBER

Applicant Cp Medical

K number K041894

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GAT 2004-08-05

ARTHREX FIBERWIRE WITH SILK

Applicant Arthrex, Inc.

K number K041589

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GAT 2004-06-07

SMITH & NEPHEW ULTRABRAID SUTURE

Applicant Smith & Nephew, Inc.

K number K041216

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GAT 2004-06-04

DURABRAID SUTURE

Applicant Smith & Nephew, Inc.

K number K040789

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GAT 2004-03-15

FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE

Applicant Teleflex Medical

K number K040472

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GAT 2004-03-01

LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999

Applicant Lsi Solutions

K number K040232

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GAT 2004-02-12

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

Applicant Arthrotek, Inc.

K number K033718

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GAT 2004-01-15

FORCE FIBER

Applicant Teleflex Medical

K number K033654

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GAT 2004-01-14

ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239

Applicant Arthrex, Inc.

K number K032245

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GAT 2003-12-02

STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM

Applicant Stryker Endoscopy

K number K032901

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GAT 2003-06-18

DEMETECH POLYESTER NONABSORBABLE SUTURE

Applicant Demetech Corp.

K number K023030

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GAT 2002-11-07

ARTHREX FIBERWIRE IN USP SIZES

Applicant Arthrex, Inc.

K number K021434

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GAT 2002-08-20

SAPH-LOOP LIGATING LOOP

Applicant Genzyme Biosurgery

K number K022410

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GAT 2002-06-18

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE

Applicant Genzyme Corp.

K number K021019

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GAT 2002-05-20

SERRALESTER

Applicant Serral, S.A. DE C.V.

K number K020902

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GAT 2002-02-27

LIFESTITCH SUTURING DEVICE

Applicant Edwards Lifesciences, LLC

K number K013990

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GAT 2001-10-04

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201

Applicant Arthrex, Inc.

K number K012923

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GAT 2001-09-19

PREMICRON NONABSORBABLE PET SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K012201

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GAT 2001-08-28

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

Applicant Xiros Plc

K number K002172

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GAT 2001-05-14

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800

Applicant Arthrex, Inc.

K number K010673

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GAT 2001-03-05

GRAMS POLYESTER NONABSORBABLE SUTURE

Applicant Gramsmed, LLC

K number K003590

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GAT 2000-11-13

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K001440

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GAT 2000-06-23

POLYESTER NONABSORBABLE SURGICAL SUTURES URP

Applicant Cp Medical

K number K001172

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GAT 2000-06-12

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K001434

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GAT 2000-04-27

POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

Applicant Arc Medical Supplies (Beijing) Co, Ltd.

K number K000540

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GAT 2000-02-04

POLYESTER

Applicant Trading Consultants and Distributors Intl., Inc.

K number K994000

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GAT 1999-04-01

NOVAFIL AND VASCUFIL STERILE SYNTHETIC NON-ABSORBABLE SUTURES

Applicant United States Surgical, A Division of Tyco Healthc

K number K990952

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GAT 1999-03-01

PRE-THREADED ENDOBUTTON

Applicant Smith & Nephew, Inc.

K number K984550

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GAT 1999-02-10

SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K990088

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GAT 1998-04-25

AUTO SUTUREENDOSTITCH II** SUTURE APPLIER

Applicant United States Surgical, A Division of Tyco Healthc

K number K972911

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GAT 1998-04-01

ENDOBUTTON CONTINUOUS LOOP

Applicant Smith & Nephew, Inc.

K number K980155

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GAT 1997-04-21

ACUFEX DOUBLE ARMED SUTURE NEEDLE

Applicant Smith & Nephew Endoscopy, Inc.

K number K970416

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GAT 1996-07-29

POLYESTER NONABSORBABLE SURGICAL SUTURES USP

Applicant R. K. Medical L. L. C.

K number K961925

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GAT 1996-04-15

EXPANDED BODY SUTURE

Applicant Medicinelodge, Inc.

K number K961025

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GAT 1996-02-27

USSC NONABSORBABLE SUTURES

Applicant United States Surgical, A Division of Tyco Healthc

K number K955747

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GAT 1996-02-08

ACUFEX ENDOBUTTON TAPE

Applicant Acufex Microsurgical, Inc.

K number K952535

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GAT 1994-12-05

SURGIBOND

Applicant Sutures , Ltd.

K number K943221

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GAT 1994-12-05

SUTULENE

Applicant Sutures , Ltd.

K number K943220

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GAT 1994-11-10

POLYVIOLENE SURGICL SUTURE

Applicant Look, Inc.

K number K943949

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GAT 1994-03-03

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER

Applicant Surgimetrics International, Ltd.

K number K931916

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GAT 1994-01-07

SUTURE NONABSORBABLE- SILK, POLYESTER

Applicant Surgical Specialties, Inc.

K number K932038

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GAT 1993-12-17

BRAIDED POLYESTER SURGICAL SUTURE

Applicant Lukens Medical Corp.

K number K930945

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GAT 1993-12-17

LUKENS SILK SURGICAL SUTURE

Applicant Lukens Medical Corp.

K number K930942

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GAT 1993-12-17

TI-CRON AND DACRON SUTURES

Applicant Davis & Geck, Inc.

K number K930591

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GAT 1993-12-17

SILK SUTURES

Applicant Davis & Geck, Inc.

K number K930590

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GAT 1993-12-17

POLYVIOLENE SUTURE-REVISED LABELING

Applicant Look, Inc.

K number K926167

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GAT 1993-12-13

MEDSURG MARSHMALLOW TRAY

Applicant Medsurg Industries, Inc.

K number K920421

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