K062365 is an FDA 510(k) clearance for the ARTHREX ASPIRATE KIT. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 29, 2006, 46 days after receiving the submission on August 14, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K062365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2006 |
| Decision Date | September 29, 2006 |
| Days to Decision | 46 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 |