K161606 is an FDA 510(k) clearance for the Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on February 10, 2017, 245 days after receiving the submission on June 10, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K161606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2016 |
| Decision Date | February 10, 2017 |
| Days to Decision | 245 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 |