# K124052: Ostavi Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Feb 26, 2013 after 57 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 1.
- K000011: Modified Hydrophilic Coated Guidewire, Lake Region Mfg., Inc. (2000) Summary page 2.

## Indications for use
The endloscopic guidewire is intended for use in selective cannulation of the blilary ducts including, but not limited to the common bile, pancreatic, cystic, right and left hepatic ducts. The endloscopic guidewire is designed to be used during endloscopic pancreatic-biliary procedures for catheter Introduction and exchanges of catheters, cannulas and sphicterotornes.

Source page: https://510kreport.com/device/K124052
Methodology: https://510kreport.com/methodology