K002261 is an FDA 510(k) clearance for the MR-III. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyester (Class II - Special Controls, product code GAS).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 23, 2000, 90 days after receiving the submission on July 25, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K002261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2000 |
| Decision Date | October 23, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAS — Suture, Nonabsorbable, Synthetic, Polyester |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |