# K103437: US Endoscopy Cytology Brush

- Pathway: 510(k) (Special)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Dec 23, 2010 after 30 days
- Product code: FDX (Endoscopic Cytology Brush)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K142695: Cytosponge Cell Collection Device (2014), 4 descendants of its own
- K152794: Cytosponge Cell Collection Device (2016), 3 descendants of its own
- K181020: Cytosponge Cell Collection Device (2018), 2 descendants of its own
- K233142: EndoSign® Cell collection device (ES-CYT-102) (2024), 0 descendants of its own
- K203450: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (2021), 0 descendants of its own

## Recalls of this device
- Dec 22, 2011 · Class II · Z-2396-2012: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

## Indications for use
The disposable Cytology Brush is intended to be used to retrieve cytological cell samples in the gastrointestinal tract

Source page: https://510kreport.com/device/K103437
Methodology: https://510kreport.com/methodology