# K250993: Single Use Cytology Brush V (BC-V600P-3010)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Dec 18, 2025 after 262 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: 5 generations back to K896318 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192908: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes, Wilson-Cook Medical, Inc. (2019) Summary page 5.

## Indications for use
The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.

Source page: https://510kreport.com/device/K250993
Methodology: https://510kreport.com/methodology