K003017 is an FDA 510(k) clearance for the GRAMSORB SYNTHETIC ABSORBABLE SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on March 13, 2001, 167 days after receiving the submission on September 27, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K003017 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2000 |
| Decision Date | March 13, 2001 |
| Days to Decision | 167 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 |