# K171573: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Dec 29, 2017 after 213 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: 2 generations back to K896318 (1990). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040324: Wilson-Cook Double Lumen Biliary Cytology Brush, Wilson-Cook Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collection of cells in the biliary system.

Source page: https://510kreport.com/device/K171573
Methodology: https://510kreport.com/methodology