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FDA 510(k)

NovoFine® Plus

K-Number: K231255 · 2023-08-25

ApplicantNovo Nordisk, Inc.
Decision Date2023-08-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovoFine® Plus is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K231255. 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® Plus?

NovoFine® Plus is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K231255.

When did NovoFine® Plus receive FDA 510(k) clearance?

NovoFine® Plus received FDA 510(k) clearance on 2023-08-25, under 510(k) number K231255.

Who is the listed applicant for NovoFine® Plus?

The FDA 510(k) record lists Novo Nordisk, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoFine® Plus?

The FDA product code for NovoFine® Plus is FMI.

Other records listing Novo Nordisk, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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