K962480 is an FDA 510(k) clearance for the COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 1996, 37 days after receiving the submission on June 26, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K962480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1996 |
| Decision Date | August 02, 1996 |
| Days to Decision | 37 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 |