# K133076: Novagold High Performance Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Feb 20, 2014 after 143 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910497 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122816: Axcess Soft Tip Wire Guide, Wilson-Cook Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K150225: NovaGold High Performance Guidewire (2015), 0 descendants of its own

## Recalls of this device
- Mar 31, 2014 · Class II · Z-1747-2014: Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

## 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 encloscopic procedures.

Source page: https://510kreport.com/device/K133076
Methodology: https://510kreport.com/methodology