# K040800: Wilosn-Cook Biliary Dilation Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 25, 2004 after 88 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 K935094 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935094: Balloon Dilation Catheter, Wilson-Cook Medical, Inc. (1995) Summary page 1.
- K001338: Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter, Boston Scientific Corp (2000). Our reading of the summary gave K011338, FDA’s number for Oto-Cem (Ototech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Microvasive RX Biliary Balloon Dilation Catheter”.

## Indications for use
The Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures of the biliary tree. This device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K040800
Methodology: https://510kreport.com/methodology