Panels › General, Plastic Surgery › Product code GAR · Class 2
Suture, Nonabsorbable, Synthetic, Polyamide
Regulation 878.5020
1510(k)s in 12 months (57 all time)
1recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in GAR
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LP | 0 | 6 |
| Aesculap, Inc. | 3 | 1 |
| S. Jackson, Inc. | 4 | 0 |
| Look, Inc. | 3 | 0 |
| Riverpoint Medical | 1 | 2 |
| Surgical Specialties, Inc. | 1 | 2 |
| Sutures , Ltd. | 3 | 0 |
| Tas Medical, Inc. | 2 | 1 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Artimplant AB | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 1991 | K903177 | ADVANCE SUTURE NONABSORBABLE NYLON SUTURE Advance Suture, Inc. | GAR |
| Feb 11, 1991 | K905286 | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. | GAR |
| Jan 29, 1991 | K904931 | AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* United States Surgical, A Division of Tyco Healthc | GAR |
| Jan 17, 1991 | K905379 | AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP United States Surgical, A Division of Tyco Healthc | GAR |
| Oct 25, 1990 | K904052 | SUPRAMID EXTRA SUTURES S. Jackson, Inc. | GAR |
| Oct 25, 1990 | K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE Look, Inc. | GAR |
| Jul 5, 1990 | K900531 | NONABSORBABLE NYLON SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc | GAR |
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