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FDA 510(k)

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

K-Number: K161606 · 2017-02-10

ApplicantTerumo Europe N.V.
Decision Date2017-02-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is a medical device manufactured by Terumo Europe N.V.. It received FDA 510(k) clearance on 2017-02-10 under approval number K161606. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Terumo Europe N.V.. The 510(k) number is K161606.

When was Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH approved by the FDA?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH received FDA 510(k) clearance on 2017-02-10, under approval number K161606.

What company makes Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is manufactured by Terumo Europe N.V..

What is the FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

The FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is FMF.

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Other Devices by Terumo Europe N.V.

K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall K212095SurGuard3 Safety Hypodermic Needle K230951Terumo Injection Filter Needle (NF-3013RBKE05M) K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

View all 7 devices →

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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