# K984168: Barrett's Esophageal Cytology Device

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Dec 7, 1999 after 382 days
- Product code: FCF (Instrument, Biopsy, Mechanical, Gastrointestinal)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Barrett’s Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of Cytologic-analysis to determine the presence of abnormalities like Barrett’s Esophagus.

Source page: https://510kreport.com/device/K984168
Methodology: https://510kreport.com/methodology