# K142695: Cytosponge Cell Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Nov 26, 2014 after 65 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: 1 generation back to K934193 (1993). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934193: Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst, Biosearch Medical Products, Inc. (1993) Summary page 6.
- K103437: US Endoscopy Cytology Brush, United States Endoscopy Group, Inc. (2010) Summary page 6.

## Most influential descendants
- 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

## Indications for use
The Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Source page: https://510kreport.com/device/K142695
Methodology: https://510kreport.com/methodology