# K040324: Wilson-Cook Double Lumen Biliary Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: May 20, 2004 after 100 days
- Product code: FDX (Endoscopic Cytology Brush)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K896318 (1990). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896318: Wilson-Cook Cytology Brushes, Wilson-Cook Medical, Inc. (1990) Summary page 1.

## Most influential descendants
- K171573: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (2017), 3 descendants of its own
- K181317: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (2019), 2 descendants of its own
- K192908: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (2019), 1 descendant of its own
- K250993: Single Use Cytology Brush V (BC-V600P-3010) (2025), 0 descendants of its own
- K052279: Cook Ireland Echobrush (2005), 0 descendants of its own

## Indications for use
The Wilson-Cook Double Lumen Biliary Cytology Brush is intended for the collection of cells in the biliary system. The device is supplied sterile and intended for single use only

Source page: https://510kreport.com/device/K040324
Methodology: https://510kreport.com/methodology