K013671 is an FDA 510(k) clearance for the L-25 ABSORBABLE SURIGCAL 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 January 8, 2002, 63 days after receiving the submission on November 6, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K013671 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2001 |
| Decision Date | January 08, 2002 |
| Days to Decision | 63 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 |