# K040129: Tri-EX Extraction Balloon with Multiple Sizing

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Feb 27, 2004 after 37 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: 1 generation back to K953951 (1995). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953951: Wilson-Cook Triple Lumen Balloon Stone Extractor, Wilson-Cook Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K170292: Tri-Ex Extraction Balloon With Multiple Sizing (2017), 6 descendants of its own
- K200173: Stone Retrieval Balloon (2020), 3 descendants of its own
- K063677: Fusion Quattro Extraction Balloon XL (2007), 2 descendants of its own
- K210660: Stone Retrieval Balloon Catheter (2021), 1 descendant of its own
- K253013: Disposable Stone Retrieval Balloon Catheter (2026), 0 descendants of its own

## Indications for use
The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.

Source page: https://510kreport.com/device/K040129
Methodology: https://510kreport.com/methodology