# K173414: Advance Biliary Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 22, 2018 after 233 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 K011018 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011018: Taut Balloon Catheter, Model 50640, Taut, Inc. (2001) Summary page 4.

## Most influential descendants
- K212582: SpyGlass Discover Balloon Dilation Catheter (2022), 0 descendants of its own

## Indications for use
The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

Source page: https://510kreport.com/device/K173414
Methodology: https://510kreport.com/methodology