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 Dec 06, 2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683
Abbott Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Sep 25, 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865
Sutura, Inc.
General & Plastic Surgery · 29d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990
American Medical Systems, Inc.
General & Plastic Surgery · 80d
Cleared Apr 09, 2001
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K010909
Tyco Healthcare Group LP
General & Plastic Surgery · 14d
Cleared Dec 18, 2000
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
K002999
Gramsmed, LLC
General & Plastic Surgery · 83d
Cleared Oct 06, 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557
Axya Medical, Inc.
General & Plastic Surgery · 50d
Cleared Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703
Abbott Vascular, Inc.
General & Plastic Surgery · 120d
Cleared Aug 24, 2000
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K002435
Axya Medical, Inc.
General & Plastic Surgery · 15d
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185
Cp Medical
General & Plastic Surgery · 73d
Cleared Apr 27, 2000
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
K000537
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 70d
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 Mar 03, 1994
SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE
K931917
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Dec 17, 1993
REVISED LABELING FOR POLYPROPYLENE SUTURE
K926588
Look, Inc.
General & Plastic Surgery · 381d