# K052279: Cook Ireland Echobrush

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Oct 11, 2005 after 50 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934356: Wilson-Cook GI Aspiration Needle, Wilson-Cook Medical, Inc. (1994) Summary page 1.
- K040324: Wilson-Cook Double Lumen Biliary Cytology Brush, Wilson-Cook Medical, Inc. (2004) Summary page 1.

## Indications for use
The EchoBrush TM is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K052279
Methodology: https://510kreport.com/methodology