Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH— 510(k) K161606

Substantially Equivalent

Terumo Europe N.V.

FDA 510(k) clearance K161606 for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH, Substantially Equivalent on 2017-02-10. Applicant: Terumo Europe N.V..

Clearance details

Applicant: Terumo Europe N.V.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2016-06-10
Decision date: 2017-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.