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
49–72 of 85
Cleared Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185
Cp Medical
General & Plastic Surgery · 73d
Cleared Feb 04, 2000
POLYPROPYLENE
K993997
Trading Consultants and Distributors Intl., Inc.
General & Plastic Surgery · 72d
Cleared Jan 13, 2000
MODIFICATION TO BONE ANCHOR AND KIT (BAK)
K994313
Axya Medical, Inc.
General & Plastic Surgery · 22d
Cleared Sep 22, 1999
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
K992405
Axya Medical, Inc.
General & Plastic Surgery · 64d
Cleared Nov 27, 1998
SUTURE WELDING SYSTEM AND KIT (SWK)
K983108
Axya Medical, Inc.
General & Plastic Surgery · 84d
Cleared May 04, 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared Jun 18, 1996
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K961389
R. K. Medical L. L. C.
General & Plastic Surgery · 69d
Cleared May 16, 1996
VIEWPOINT
K961168
Philips Medical Systems (Cleveland), Inc.
General & Plastic Surgery · 52d
Cleared Apr 04, 1996
CPR HEART PACK
K960209
Custom Pack Reliability
General & Plastic Surgery · 79d
Cleared Feb 27, 1996
USSC POLYPROPLENE SUTURE
K954808
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 131d
Cleared Jan 31, 1996
PRODEK
K953609
Sutures , Ltd.
General & Plastic Surgery · 182d
Cleared Jan 24, 1995
SURGILENE(R) SUTURES
K945701
Davis & Geck, Inc.
General & Plastic Surgery · 76d
Cleared Dec 17, 1993
REVISED LABELING FOR POLYPROPYLENE SUTURE
K926588
Look, Inc.
General & Plastic Surgery · 381d
Cleared Dec 17, 1993
SURGILENE POLYPROPYLENE SUTURE
K930587
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
MOPYLEN SUTURE
K931614
S. Jackson, Inc.
General & Plastic Surgery · 260d
Cleared Jul 30, 1992
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437
Ethicon, Inc.
General & Plastic Surgery · 178d
Cleared Jul 02, 1991
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
K911905
Deknatel, Inc.
General & Plastic Surgery · 74d
Cleared Dec 24, 1990
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643
Deknatel, Inc.
General & Plastic Surgery · 136d
Cleared Oct 11, 1990
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K903584
Look, Inc.
General & Plastic Surgery · 64d
Cleared Sep 27, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d