# K153264: EasyPass Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corporation
- Decided: May 19, 2016 after 189 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 K922302 (1992). 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)
- K081708: Taxi Endoscopic Guidewire, Lake Region Mfg., Inc. (2008) Summary page 5.

## Indications for use
The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

Source page: https://510kreport.com/device/K153264
Methodology: https://510kreport.com/methodology