K201816 is an FDA 510(k) clearance for the ARTHROTAP. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Accuro Technologies, Inc. (Victoria, CA). The FDA issued a Cleared decision on October 16, 2020, 107 days after receiving the submission on July 1, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2020 |
| Decision Date | October 16, 2020 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |