# K953951: Wilson-Cook Triple Lumen Balloon Stone Extractor

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Sep 19, 1995 after 28 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040129: Tri-EX Extraction Balloon with Multiple Sizing (2004), 10 descendants of its own
- 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

## Recalls of this device
- Aug 28, 2002 · Not classified · Z-0068-04: The product was labeled with a 5 year expiration date instead of a 1 year expiration date.

Source page: https://510kreport.com/device/K953951
Methodology: https://510kreport.com/methodology