# K190164: CleverLock Guidewire Locking Device and Biopsy Cap

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Surgical Technologies America
- Decided: Apr 4, 2019 after 63 days
- Product code: ODC (Endoscope Channel Accessory)
- 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 K970054 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040137: Wilson-Cook Usw Cap and Wire Lock, Wilson-Cook Medical, Inc. (2004) Summary page 4.

## Indications for use
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.

Source page: https://510kreport.com/device/K190164
Methodology: https://510kreport.com/methodology