Clearance Summary
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH received FDA 510(k) clearance under submission number K161606, sponsored by Terumo Europe N.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-02-10.
- Submission: K161606
- Applicant / Sponsor: Terumo Europe N.V.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2017-02-10
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.