K003000 is an FDA 510(k) clearance for the GRAMS NYLON NONABSORBABLE SUTURE, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on December 18, 2000, 83 days after receiving the submission on September 26, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K003000 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2000 |
| Decision Date | December 18, 2000 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAR — Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5020 |