# K181020: Cytosponge Cell Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Aug 16, 2018 after 121 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934193 (1993). 4 ancestors in all.
2 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)
- K152794: Cytosponge Cell Collection Device, Covidien, LLC (2016) Summary page 4.
- K142695: Cytosponge Cell Collection Device, Covidien, LLC (2014) Summary page 4.

## Most influential descendants
- 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 2, 2023 · Class II · Z-2282-2023: Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, air

## 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/K181020
Methodology: https://510kreport.com/methodology