K020597 is an FDA 510(k) clearance for the SERRALGUT, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on August 14, 2002, 173 days after receiving the submission on February 22, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K020597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 22, 2002 |
| Decision Date | August 14, 2002 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |