# K191485: Deflectable Brush Biopsy Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 26, 2019 after 22 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 K770913 (1977). 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)
- K810372: Vance Deflectable Biopsy Brush Set, Vance Products, Inc. (1981) Summary page 4.
- K770913: Urological Biopsy Brush Set, Cook, Inc. (1977) Summary page 4.

## Indications for use
The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

Source page: https://510kreport.com/device/K191485
Methodology: https://510kreport.com/methodology