# K151471: Radifocus Glidewire Endoscopic Wire

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Sep 17, 2015 after 108 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: 1 generation back to K910722 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910722: 450CM Guide Wire for G.I. Use, Terumo Corp. (1991) Summary page 5.

## Indications for use
The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Source page: https://510kreport.com/device/K151471
Methodology: https://510kreport.com/methodology