# K173479: NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Jan 17, 2018 after 65 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951254 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062500: Flexpen Needle, Novo Nordisk, Inc. (2006) Summary page 4.
- K090111: Flexpen Needle, Novo Nordisk, Inc. (2010) Summary page 4.

## Most influential descendants
- K210258: NovoFine (2021), 0 descendants of its own

## Indications for use
Indications for Use: NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.

Source page: https://510kreport.com/device/K173479
Methodology: https://510kreport.com/methodology