510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002403Substantially Equivalent

Novofine 31 Disposable Needle

Novo Norodisk Pharmaceuticals, Inc., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002403 is the FDA 510(k) clearance record for NOVOFINE 31 DISPOSABLE NEEDLE, a class II device, cleared for Novo Norodisk Pharmaceuticals, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list one 510(k) clearance for Novo Norodisk Pharmaceuticals, Inc. As of , FDA records show no recalls naming K002403.

Clearance record

Decision date
Received
(123 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Novo Norodisk Pharmaceuticals, Inc. 100 Overlook Center Suite 200, Princeton NJ
510(k) summary
Summary
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260