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510(k) K210258

NovoFine by Novo Nordisk, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2021
Date Received
February 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Novo Nordisk, Inc.

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  • K202005 — NovoFine Plus 32G Tip x 4 mm (December 19, 2020)
  • K182387 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (December 17, 2018)
  • K173479 — NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (January 17, 2018)
  • K162602 — NovoPen Echo (October 18, 2016)
  • K150874 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (July 31, 2015)
  • K133738 — NOVOFINE PLUS 32G 4 MM (May 21, 2014)
  • K123766 — NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN (August 15, 2013)
  • K093109 — NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (June 18, 2010)
  • K090111 — FLEXPEN NEEDLE (February 1, 2010)

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  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
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  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)