K000037 is an FDA 510(k) clearance for the MONOFILAMENT BIOSYN SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on March 30, 2000, 84 days after receiving the submission on January 6, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K000037 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2000 |
| Decision Date | March 30, 2000 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4493 |