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FDA 510(k)

NovoFine Plus 32G Tip x 4 mm

K-Number: K202005 · 2020-12-19

ApplicantNovo Nordisk, Inc.
Decision Date2020-12-19
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovoFine Plus 32G Tip x 4 mm 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 2020-12-19 under 510(k) number K202005. 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 32G Tip x 4 mm?

NovoFine Plus 32G Tip x 4 mm is a medical device that received FDA 510(k) clearance on 2020-12-19. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K202005.

When did NovoFine Plus 32G Tip x 4 mm receive FDA 510(k) clearance?

NovoFine Plus 32G Tip x 4 mm received FDA 510(k) clearance on 2020-12-19, under 510(k) number K202005.

Who is the listed applicant for NovoFine Plus 32G Tip x 4 mm?

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 32G Tip x 4 mm?

The FDA product code for NovoFine Plus 32G Tip x 4 mm 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.

K231255NovoFine® PlusK210258NovoFineK182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)K162602NovoPen Echo

Related Devices (Code: FMI)

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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