K032586 is an FDA 510(k) clearance for the CAPROSYN ABSORBABLE 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 November 17, 2003, 87 days after receiving the submission on August 22, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K032586 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2003 |
| Decision Date | November 17, 2003 |
| Days to Decision | 87 days |
| Submission Type | Abbreviated |
| 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 |