# K003571: Serono for Use with Gonal-F 1200IU Multi-Dose Only at 600IU/ML Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Terumo Medical Corp.
- Decided: Feb 12, 2001 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161606: Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K003571
Methodology: https://510kreport.com/methodology