Suture, Nonabsorbable, Synthetic, Polypropylene

FDA product code GAW · 80 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5010
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1990-09-27 – 2026-03-27

GAW 2026-03-27

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

Applicant ETHICON, Inc.

K number K253572

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GAW 2024-01-12

Cypris eXact Suturing System

Applicant Cypris Medical

K number K233355

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GAW 2023-09-14

Non absorbable Surgical Polypropylene Suture

Applicant Shandong Haidike Medical Products Co., Ltd.

K number K230746

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GAW 2022-12-09

Vesseal

Applicant Lydus Medical , Ltd.

K number K221280

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GAW 2022-09-02

DURAMESH Mesh Suture

Applicant Msi

K number K211178

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GAW 2020-08-27

APTOS Threads – Polypropylene Surgical Sutures

Applicant Aptos, LLC

K number K192953

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GAW 2020-03-19

Deklene MAXX

Applicant Teleflex Medical

K number K193530

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GAW 2019-06-14

Silhouette Featherlift / Silhouette Lift

Applicant Silhouette Lift, Inc.

K number K191299

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GAW 2018-12-21

REXLENE

Applicant Sm Eng Co., Ltd.

K number K173747

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GAW 2018-03-07

Aesculap Optilene Nonabsorbable Suture

Applicant Aesculap, Inc.

K number K180321

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GAW 2018-02-15

Gazelle Polypropylene Suture and Delivery Device

Applicant Dura Tap, LLC

K number K173644

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GAW 2017-08-29

Assut Filbloc Permanent Sutures

Applicant Assut Europe S.P.A.

K number K171039

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GAW 2017-05-03

Silhouette Featherlift

Applicant Silhouette Lift, Inc.

K number K171005

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GAW 2017-04-06

NobleStitch EL

Applicant Nobles Medical Technologies Ii, Inc.

K number K162617

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GAW 2016-09-15

Pledgeted COR-SUTURE QUICK LOAD

Applicant Lsi Soultions

K number K160529

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GAW 2013-12-06

PROLENE POLYPROPYLENE NONABSORBABLE SUTURE

Applicant ETHICON, Inc.

K number K133356

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GAW 2013-05-16

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE

Applicant Surgical Specialties Corp. Dba Angiotech

K number K131224

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GAW 2013-02-28

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Applicant Surgical Specialties Corp. Dba Angiotech

K number K130078

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GAW 2012-04-19

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA

Applicant Nobles Medical Technologies Ii, Inc.

K number K113494

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GAW 2012-03-16

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE

Applicant Nobles Medical Technologies Ii, Inc.

K number K113763

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GAW 2012-01-20

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE

Applicant Angiotech

K number K113800

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GAW 2010-10-13

SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME

Applicant Lsi Solutions, Inc.

K number K100593

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GAW 2010-02-01

DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE

Applicant Coloplast Manufacturing Us, LLC

K number K093112

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GAW 2007-04-17

SUTRALENE POLYPROPYLENE SUTURES

Applicant Visionary Medical Supplies, Inc.

K number K070243

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GAW 2006-10-26

NEOTRACT ANCHOR

Applicant Neotract, Inc.

K number K061700

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GAW 2006-10-23

KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE

Applicant Kmi Kolster Methods, Inc.

K number K060414

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GAW 2006-10-19

SUPERSTITCH 5F, 12F, AND EL

Applicant Sutura, Inc.

K number K062125

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GAW 2005-12-27

SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

Applicant Sutura, Inc.

K number K053482

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GAW 2005-12-13

COROLENE

Applicant Peters Surgical

K number K052701

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GAW 2005-12-06

OPTIMIZED BARB DESIGN

Applicant Surgical Specialties Corp

K number K052962

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GAW 2005-09-26

QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE

Applicant Quill Medical, Inc.

K number K052373

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GAW 2005-06-03

TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE

Applicant Sutures India Private Limited

K number K041511

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GAW 2005-06-01

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K050947

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GAW 2005-05-16

POLYPROPILENE SURGICAL SUTURES

Applicant Demetech Corp.

K number K043330

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GAW 2005-04-01

CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS

Applicant Surgical Specialties Corp

K number K050548

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GAW 2005-03-04

CONTOUR NECKLIFT THREADS

Applicant Surgical Specialties Corp

K number K050247

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GAW 2005-03-04

FEATHERLIFT EXTENDED APTOS THREAD

Applicant Kmi Kolster Methods, Inc.

K number K043591

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GAW 2004-12-03

CONTOUR FOREHEAD/BROWLIFT THREAD

Applicant Surgical Specialties Corp

K number K042856

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GAW 2004-12-01

UNIPRO

Applicant United Medical Industries Co. , Ltd.

K number K042283

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GAW 2004-09-20

FEATHERLIFT EXTENDED LENGTH APTOS THREAD

Applicant Surgical Specialties Corp

K number K041593

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GAW 2002-08-28

SUTURE FIXATION DEVICE; MESH FIXATION DEVICE

Applicant Mle, Inc.

K number K021834

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GAW 2002-04-17

SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X

Applicant Sutura, Inc.

K number K020940

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GAW 2002-03-08

SERRALENE, MODEL CATALOG NO 1S

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

K number K020265

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GAW 2001-12-06

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

Applicant Abbott Vascular, Inc.

K number K013683

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GAW 2001-09-25

SUPERSTITCH VASCULAR SUTURING DEVICE

Applicant Sutura, Inc.

K number K012865

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GAW 2001-06-22

AMS SLING FIXATION SYSTEM

Applicant American Medical Systems, Inc.

K number K010990

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GAW 2001-04-09

NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

Applicant Tyco Healthcare Group LP

K number K010909

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GAW 2000-12-18

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE

Applicant Gramsmed, LLC

K number K002999

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GAW 2000-10-06

SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

Applicant Axya Medical, Inc.

K number K002557

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GAW 2000-10-03

PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

Applicant Abbott Vascular, Inc.

K number K001703

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GAW 2000-08-24

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

Applicant Axya Medical, Inc.

K number K002435

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GAW 2000-07-10

PRONOVA NONABSORBABLE SUTURE, USP

Applicant ETHICON, Inc.

K number K001625

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GAW 2000-06-23

POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP

Applicant Cp Medical

K number K001185

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GAW 2000-04-27

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

Applicant Arc Medical Supplies (Beijing) Co, Ltd.

K number K000537

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GAW 2000-02-04

POLYPROPYLENE

Applicant Trading Consultants and Distributors Intl., Inc.

K number K993997

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GAW 2000-01-13

MODIFICATION TO BONE ANCHOR AND KIT (BAK)

Applicant Axya Medical, Inc.

K number K994313

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GAW 1999-09-22

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

Applicant Axya Medical, Inc.

K number K992405

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GAW 1998-11-27

SUTURE WELDING SYSTEM AND KIT (SWK)

Applicant Axya Medical, Inc.

K number K983108

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GAW 1998-05-04

PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K980703

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GAW 1996-06-18

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES

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

K number K961389

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GAW 1996-05-16

VIEWPOINT

Applicant Philips Medical Systems (Cleveland), Inc.

K number K961168

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GAW 1996-04-04

CPR HEART PACK

Applicant Custom Pack Reliability

K number K960209

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GAW 1996-02-27

USSC POLYPROPLENE SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K954808

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GAW 1996-01-31

PRODEK

Applicant Sutures , Ltd.

K number K953609

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GAW 1995-01-24

SURGILENE(R) SUTURES

Applicant Davis & Geck, Inc.

K number K945701

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GAW 1994-03-03