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FDA 510(k)

NovoFine

K-Number: K210258 · 2021-06-23

ApplicantNovo Nordisk, Inc.
Decision Date2021-06-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovoFine is a medical device manufactured by Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2021-06-23 under approval number K210258. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoFine?

NovoFine is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by Novo Nordisk, Inc.. The 510(k) number is K210258.

When was NovoFine approved by the FDA?

NovoFine received FDA 510(k) clearance on 2021-06-23, under approval number K210258.

What company makes NovoFine?

NovoFine is manufactured by Novo Nordisk, Inc..

What is the FDA product code for NovoFine?

The FDA product code for NovoFine is FMI.

Other Devices by Novo Nordisk, Inc.

K162602NovoPen Echo K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) K202005NovoFine Plus 32G Tip x 4 mm K231255NovoFine® Plus

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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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