K061796 is an FDA 510(k) clearance for the HEPATOSTAT SET, MODEL 760X, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Vygon Corp. (Farmington Hills, US). The FDA issued a Cleared decision on November 2, 2006, 129 days after receiving the submission on June 26, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K061796 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2006 |
| Decision Date | November 02, 2006 |
| Days to Decision | 129 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 |