K091018 is an FDA 510(k) clearance for the ARTHREX BIOWIRE. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyester (Class II - Special Controls, product code GAS).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 30, 2010, 477 days after receiving the submission on April 9, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K091018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2009 |
| Decision Date | July 30, 2010 |
| Days to Decision | 477 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 |