# K142397: Predicate III Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Sep 19, 2014 after 23 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: 3 generations back to K970994 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001) Summary page 4.
- K140482: Mandrel Guidewire, Lake Region Medical (2014) Summary page 4.

## Indications for use
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

Source page: https://510kreport.com/device/K142397
Methodology: https://510kreport.com/methodology