GAW · Class II · 21 CFR 878.5010

FDA Product Code GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Leading manufacturers include Axya Medical, Inc., Surgical Specialties Corp and Ethicon, Inc..

85
Total
85
Cleared
125d
Avg days
1990
Since
85 devices
25–48 of 85
Cleared Mar 16, 2012
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
K113763
Nobles Medical Technologies Ii, Inc.
General & Plastic Surgery · 86d
Cleared Jan 20, 2012
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
K113800
Angiotech
General & Plastic Surgery · 28d
Cleared Oct 13, 2010
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
K100593
Lsi Solutions, Inc.
General & Plastic Surgery · 225d
Cleared Feb 01, 2010
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
K093112
Coloplast Manufacturing Us, LLC
General & Plastic Surgery · 123d
Cleared Apr 17, 2007
SUTRALENE POLYPROPYLENE SUTURES
K070243
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 82d
Cleared Oct 26, 2006
NEOTRACT ANCHOR
K061700
Neotract, Inc.
General & Plastic Surgery · 132d
Cleared Oct 23, 2006
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
K060414
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 249d
Cleared Oct 19, 2006
SUPERSTITCH 5F, 12F, AND EL
K062125
Sutura, Inc.
General & Plastic Surgery · 86d
Cleared Dec 27, 2005
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
K053482
Sutura, Inc.
General & Plastic Surgery · 13d
Cleared Dec 13, 2005
COROLENE
K052701
Peters Surgical
General & Plastic Surgery · 76d
Cleared Dec 06, 2005
OPTIMIZED BARB DESIGN
K052962
Surgical Specialties Corp
General & Plastic Surgery · 46d
Cleared Sep 26, 2005
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
K052373
Quill Medical, Inc.
General & Plastic Surgery · 27d
Cleared Jun 03, 2005
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K041511
Sutures India Private Limited
General & Plastic Surgery · 361d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 47d
Cleared May 16, 2005
POLYPROPILENE SURGICAL SUTURES
K043330
Demetech Corp.
General & Plastic Surgery · 165d
Cleared Apr 01, 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
K050548
Surgical Specialties Corp
General & Plastic Surgery · 30d
Cleared Mar 04, 2005
FEATHERLIFT EXTENDED APTOS THREAD
K043591
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 66d
Cleared Mar 04, 2005
CONTOUR NECKLIFT THREADS
K050247
Surgical Specialties Corp
General & Plastic Surgery · 30d
Cleared Dec 03, 2004
CONTOUR FOREHEAD/BROWLIFT THREAD
K042856
Surgical Specialties Corp
General & Plastic Surgery · 60d
Cleared Dec 01, 2004
UNIPRO
K042283
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 99d
Cleared Sep 20, 2004
FEATHERLIFT EXTENDED LENGTH APTOS THREAD
K041593
Surgical Specialties Corp
General & Plastic Surgery · 98d
Cleared Aug 28, 2002
SUTURE FIXATION DEVICE
K021834
Mle, Inc.
General & Plastic Surgery · 85d
Cleared Apr 17, 2002
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X
K020940
Sutura, Inc.
General & Plastic Surgery · 26d
Cleared Mar 08, 2002
SERRALENE, MODEL CATALOG NO 1S
K020265
Serral, S.A. DE C.V.
General & Plastic Surgery · 42d