# K150225: NovaGold High Performance Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Mar 16, 2015 after 42 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K910497 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133076: Novagold High Performance Guidewire, Neometrics, Inc. (2014) Summary page 4.

## Indications for use
The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

Source page: https://510kreport.com/device/K150225
Methodology: https://510kreport.com/methodology