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 a medical device manufactured by Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2018-01-17 under approval 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. It is manufactured by Novo Nordisk, Inc.. The 510(k) number is K173479.
When was NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) approved by the FDA?
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) received FDA 510(k) clearance on 2018-01-17, under approval number K173479.
What company makes 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 manufactured by Novo Nordisk, Inc..
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.
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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.