K022269 is an FDA 510(k) clearance for the COATED VICRYL* (POLYGLACTIN 910) SUTURE. 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 September 13, 2002, 60 days after receiving the submission on July 15, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K022269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2002 |
| Decision Date | September 13, 2002 |
| Days to Decision | 60 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 |