Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)

K-Number: K173479 · 2018-01-17

ApplicantNovo Nordisk, Inc.
Decision Date2018-01-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) 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 2018-01-17 under 510(k) number K173479. 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 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K173479.

When did NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) receive FDA 510(k) clearance?

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) received FDA 510(k) clearance on 2018-01-17, under 510(k) number K173479.

Who is the listed applicant for NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

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 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)?

The FDA product code for NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) 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® PlusK210258NovoFineK202005NovoFine Plus 32G Tip x 4 mmK182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)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.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

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.

↑