# K080508: Mandrel Guidewires or M-Wire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Mar 21, 2008 after 25 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 K970994 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970994: Core and Coil Assembly Guidewire, Lake Region Mfg., Inc. (1997) Summary page 2.

## Most influential descendants
- K140482: Mandrel Guidewire (2014), 1 descendant of its own
- K142397: Predicate III Guidewire (2014), 0 descendants of its own

## 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/K080508
Methodology: https://510kreport.com/methodology