FDA 510(k) Applications for Medical Device Product Code "GAW"
(Suture, Nonabsorbable, Synthetic, Polypropylene)

FDA 510(k) Number Applicant Device Name Decision Date
K013683 ABBOTT VASCULAR INC. MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE 12/06/2001
K001703 ABBOTT VASCULAR INC. PERCLOSE VASCULAR SUTURE DELIVERY DEVICE 10/03/2000
K133890 AESCULAP, INC. AESCULAP OPTILENE NONABSORBABLE SUTURE 07/15/2014
K180321 Aesculap, Inc. Aesculap Optilene Nonabsorbable Suture 03/07/2018
K980703 AESCULAP, INC. PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE 05/04/1998
K010990 AMERICAN MEDICAL SYSTEMS, INC. AMS SLING FIXATION SYSTEM 06/22/2001
K151112 ANGIOTECH Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design 09/10/2015
K113800 ANGIOTECH QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE 01/20/2012
K192953 APTOS, LLC. APTOS Threads û Polypropylene Surgical Sutures 08/27/2020
K000537 ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP 04/27/2000
K171039 Assut Europe S.p.A. Assut Filbloc Permanent Sutures 08/29/2017
K992405 AXYA MEDICAL, INC. AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) 09/22/1999
K002435 AXYA MEDICAL, INC. MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) 08/24/2000
K994313 AXYA MEDICAL, INC. MODIFICATION TO BONE ANCHOR AND KIT (BAK) 01/13/2000
K983108 AXYA MEDICAL, INC. SUTURE WELDING SYSTEM AND KIT (SWK) 11/27/1998
K002557 AXYA MEDICAL, INC. SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) 10/06/2000
K093112 COLOPLAST MANUFACTURING US, LLC DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE 02/01/2010
K001185 CP MEDICAL POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP 06/23/2000
K960209 CUSTOM PACK RELIABILITY CPR HEART PACK 04/04/1996
K043330 DEMETECH CORP. POLYPROPILENE SURGICAL SUTURES 05/16/2005
K173644 Dura Tap LLC Gazelle Polypropylene Suture and Delivery Device 02/15/2018
K141206 EDWARDS LIFESCIENCES LLC. EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM 01/16/2015
K133356 ETHICON, INC. PROLENE POLYPROPYLENE NONABSORBABLE SUTURE 12/06/2013
K001625 ETHICON, INC. PRONOVA NONABSORBABLE SUTURE, USP 07/10/2000
K002999 GRAMSMED LLC GRAMS POLYPROPYLENE NONABSORBABLE SUTURE 12/18/2000
K043591 KMI KOLSTER METHODS, INC. FEATHERLIFT EXTENDED APTOS THREAD 03/04/2005
K060414 KMI KOLSTER METHODS, INC. KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE 10/23/2006
K100593 LSI SOLUTIONS, INC. SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME 10/13/2010
K160529 LSI SOULTIONS Pledgeted COR-SUTURE QUICK LOAD 09/15/2016
K221280 Lydus Medical Ltd. Vesseal 12/09/2022
K021834 MLE, INC. SUTURE FIXATION DEVICE; MESH FIXATION DEVICE 08/28/2002
K211178 MSi DURAMESH Mesh Suture 09/02/2022
K061700 NEOTRACT, INC. NEOTRACT ANCHOR 10/26/2006
K162617 NOBLES MEDICAL TECHNOLOGIES II, INC. NobleStitch EL 04/06/2017
K113494 NOBLES MEDICAL TECHNOLOGIES II, INC. NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA 04/19/2012
K113763 NOBLES MEDICAL TECHNOLOGIES II, INC. SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE 03/16/2012
K142639 ORIGAMI SURGICAL LLC StitchKit 12/16/2014
K052701 PETERS SURGICAL COROLENE 12/13/2005
K961168 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VIEWPOINT 05/16/1996
K052373 QUILL MEDICAL, INC. QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE 09/26/2005
K961389 R.K. MEDICAL, L.L.C. POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES 06/18/1996
K143582 RESORBA MEDICAL GMBH MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL 10/29/2015
K020265 SERRAL, S.A. DE C.V. SERRALENE, MODEL CATALOG NO 1S 03/08/2002
K230746 Shandong Haidike Medical Products Co.,Ltd. Non absorbable Surgical Polypropylene Suture 09/14/2023
K171005 Silhouette Lift Inc. Silhouette Featherlift 05/03/2017
K191299 Silhouette Lift Inc. Silhouette Featherlift / Silhouette Lift 06/14/2019
K173747 SM ENG CO., LTD REXLENE 12/21/2018
K042856 SURGICAL SPECIALTIES CORP. CONTOUR FOREHEAD/BROWLIFT THREAD 12/03/2004
K050548 SURGICAL SPECIALTIES CORP. CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS 04/01/2005
K050247 SURGICAL SPECIALTIES CORP. CONTOUR NECKLIFT THREADS 03/04/2005
K041593 SURGICAL SPECIALTIES CORP. FEATHERLIFT EXTENDED LENGTH APTOS THREAD 09/20/2004
K052962 SURGICAL SPECIALTIES CORP. OPTIMIZED BARB DESIGN 12/06/2005
K130078 SURGICAL SPECIALTIES CORP. DBA ANGIOTECH QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN 02/28/2013
K131224 SURGICAL SPECIALTIES CORP. DBA ANGIOTECH SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE 05/16/2013
K062125 SUTURA, INC. SUPERSTITCH 5F, 12F, AND EL 10/19/2006
K053482 SUTURA, INC. SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW 12/27/2005
K012865 SUTURA, INC. SUPERSTITCH VASCULAR SUTURING DEVICE 09/25/2001
K020940 SUTURA, INC. SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X 04/17/2002
K041511 SUTURES INDIA PRIVATE LIMITED TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE 06/03/2005
K953609 SUTURES LTD. PRODEK 01/31/1996
K193530 Teleflex Medical Deklene MAXX 03/19/2020
K993997 TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. POLYPROPYLENE 02/04/2000
K010909 TYCO HEALTHCARE GROUP, LP NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE 04/09/2001
K042283 UNITED MEDICAL INDUSTRIES CO. LTD. UNIPRO 12/01/2004
K050947 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE 06/01/2005
K954808 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC USSC POLYPROPLENE SUTURE 02/27/1996
K070243 VISIONARY MEDICAL SUPPLIES, INC. SUTRALENE POLYPROPYLENE SUTURES 04/17/2007


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