# K161606: Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Feb 10, 2017 after 245 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003571 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003571: Serono for Use with Gonal-F 1200IU Multi-Dose Only at 600IU/ML Syringe, Terumo Medical Corp. (2001) Summary page 5.

## Indications for use
The "Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH" is a hypodermic syringe with fixed needle intended for manual aspiration of GONAL-f Multi-Dose and for the injection of this solution into parts of the body below the surface of the skin. The syringes designed for manual use are intended for use soon after filling, as they are not suitable for containing GONAL-f Multi-Dose over extended periods of time.

Source page: https://510kreport.com/device/K161606
Methodology: https://510kreport.com/methodology