# K050304: FX Wire Advanced Measurement Guidewire

- Pathway: 510(k) (Special)
- Applicant: Conmedcorp
- Decided: Mar 8, 2005 after 28 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: 2 generations back to K942677 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011759: Radius Next Generation Guidewire, Radius Medical Technologies, Inc. (2001)

## Indications for use
To be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

Source page: https://510kreport.com/device/K050304
Methodology: https://510kreport.com/methodology