# K171548: Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Oct 13, 2017 after 140 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- 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 K851956 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851960: Soehendra Biliary Dilating Catheter-SBDC-7, Wilson-Cook Medical, Inc. (1985) Summary page 4.
- K851956: VPDS-1 Vennes Pancreatic Dilation Set, Wilson-Cook Medical, Inc. (1985) Summary page 4.

## Most influential descendants
- K241801: Tornus ES (2024), 0 descendants of its own

## Indications for use
The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheters are used to dilate biliary strictures. These devices are indicated for adult use only. The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.

Source page: https://510kreport.com/device/K171548
Methodology: https://510kreport.com/methodology