# K152794: Cytosponge Cell Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 12, 2016 after 197 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934193 (1993). 3 ancestors in all.
3 later devices descend from it; 2 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)
- K142695: Cytosponge Cell Collection Device, Covidien, LLC (2014) Summary page 5.

## Most influential descendants
- 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
- Jun 6, 2016 · Class II · Z-2123-2016: Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
- Jun 6, 2016 · Class II · Z-2122-2016: Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.

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

Source page: https://510kreport.com/device/K152794
Methodology: https://510kreport.com/methodology