# K233142: EndoSign® Cell collection device (ES-CYT-102)

- Pathway: 510(k) (Traditional)
- Applicant: Cyted Limited
- Decided: Jan 19, 2024 after 114 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934193 (1993). 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)
- K181020: Cytosponge Cell Collection Device, Covidien, LLC (2018) Summary page 4.

## Indications for use
The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses.

Source page: https://510kreport.com/device/K233142
Methodology: https://510kreport.com/methodology