# K063677: Fusion Quattro Extraction Balloon XL

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 5, 2007 after 25 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: 2 generations back to K953951 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040129: Tri-EX Extraction Balloon with Multiple Sizing, Wilson-Cook Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K200247: Fusion Quattro Extraction Balloon (2020), 0 descendants of its own
- K101095: Direct Peroral Cholangioscopy Balloon (2010), 0 descendants of its own

## Indications for use
Used for endoscopic removal of stones in the biliary system and for contrast injection.

Source page: https://510kreport.com/device/K063677
Methodology: https://510kreport.com/methodology