K170218 is an FDA 510(k) clearance for the Vesco Medical NRFit Tip Syringes. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Vesco Medical, LLC (Columbus, US). The FDA issued a Cleared decision on February 24, 2017, 30 days after receiving the submission on January 25, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K170218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2017 |
| Decision Date | February 24, 2017 |
| Days to Decision | 30 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 |