Panels › General, Plastic Surgery › Product code GAW · Class 2
Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation 878.5010
1510(k)s in 12 months (85 all time)
2recalls in 12 months (28 all time)
26recalls that name a 510(k)
Top companies in GAW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 4 | 22 |
| Axya Medical, Inc. | 5 | 0 |
| Surgical Specialties Corp | 5 | 0 |
| Covidien, LP | 0 | 4 |
| Sutura, Inc. | 4 | 0 |
| Aesculap, Inc. | 3 | 0 |
| Nobles Medical Technologies Ii, Inc. | 3 | 0 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Abbott Vascular, Inc. | 2 | 0 |
| Angiotech | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2001 | K010990 | AMS SLING FIXATION SYSTEM American Medical Systems, Inc. | GAW |
| Apr 9, 2001 | K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE Tyco Healthcare Group LP | GAW |
| Dec 18, 2000 | K002999 | GRAMS POLYPROPYLENE NONABSORBABLE SUTURE Gramsmed, LLC | GAW |
| Oct 6, 2000 | K002557 | SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) Axya Medical, Inc. | GAW |
| Oct 3, 2000 | K001703 | PERCLOSE VASCULAR SUTURE DELIVERY DEVICE Abbott Vascular, Inc. | GAW |
| Aug 24, 2000 | K002435 | MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) Axya Medical, Inc. | GAW |
| Jul 10, 2000 | K001625 | PRONOVA NONABSORBABLE SUTURE, USP ETHICON, Inc. | GAW |
| Jun 23, 2000 | K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP Cp Medical | GAW |
| Apr 27, 2000 | K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP Arc Medical Supplies (Beijing) Co, Ltd. | GAW |
| Feb 4, 2000 | K993997 | POLYPROPYLENE Trading Consultants and Distributors Intl., Inc. | GAW |
| Jan 13, 2000 | K994313 | MODIFICATION TO BONE ANCHOR AND KIT (BAK) Axya Medical, Inc. | GAW |
| Sep 22, 1999 | K992405 | AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) Axya Medical, Inc. | GAW |
| Nov 27, 1998 | K983108 | SUTURE WELDING SYSTEM AND KIT (SWK) Axya Medical, Inc. | GAW |
| May 4, 1998 | K980703 | PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE Aesculap, Inc. | GAW |
| Jun 18, 1996 | K961389 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES R. K. Medical L. L. C. | GAW |
| May 16, 1996 | K961168 | VIEWPOINT Philips Medical Systems (Cleveland), Inc. | GAW |
| Apr 4, 1996 | K960209 | CPR HEART PACK Custom Pack Reliability | GAW |
| Feb 27, 1996 | K954808 | USSC POLYPROPLENE SUTURE United States Surgical, A Division of Tyco Healthc | GAW |
| Jan 31, 1996 | K953609 | PRODEK Sutures , Ltd., GB | GAW |
| Jan 24, 1995 | K945701 | SURGILENE(R) SUTURES Davis & Geck, Inc. | GAW |
| Mar 3, 1994 | K931917 | SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE Surgimetrics International, Ltd. | GAW |
| Dec 17, 1993 | K931614 | MOPYLEN SUTURE S. Jackson, Inc. | GAW |
| Dec 17, 1993 | K930941 | LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE Lukens Medical Corp. | GAW |
| Dec 17, 1993 | K930587 | SURGILENE POLYPROPYLENE SUTURE Davis & Geck, Inc. | GAW |
| Dec 17, 1993 | K926588 | REVISED LABELING FOR POLYPROPYLENE SUTURE Look, Inc. | GAW |
| Oct 20, 1992 | K922630 | MOPYLEN S. Jackson, Inc. | GAW |
| Jul 30, 1992 | K920437 | SYNTHETIC ABSORBABLE SUTURE, UNDYED ETHICON, Inc. | GAW |
| Jun 11, 1992 | K914588 | GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE Grieshaber & Co. | GAW |
| Jul 2, 1991 | K911905 | DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED Deknatel, Inc., CR | GAW |
| Jun 28, 1991 | K903176 | ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE Advance Suture, Inc. | GAW |
| Apr 25, 1991 | K911189 | STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE Internacional Farmaceutica, S.A. DE C.V. | GAW |
| Dec 24, 1990 | K904906 | SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP Chathamborough Research Group, Inc. | GAW |
| Dec 24, 1990 | K903643 | DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE Deknatel, Inc., CR | GAW |
| Oct 11, 1990 | K903584 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES Look, Inc. | GAW |
| Sep 27, 1990 | K902872 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc | GAW |
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