# K193344: Tri-Ex Extraction Balloon with Multiple Sizing

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Dec 13, 2019 after 10 days
- Product code: GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K953951 (1995). 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)
- K170292: Tri-Ex Extraction Balloon With Multiple Sizing, Wilson-Cook Medical, Inc. (2017) Summary page 4.

## Indications for use
This device is used for endoscopic removal of biliary stones and for contrast injection.

Source page: https://510kreport.com/device/K193344
Methodology: https://510kreport.com/methodology