FDA 510(k)

Cytosponge Cell Collection Device

K-Number: K181020 · 2018-08-16

Decision Date2018-08-16

Product CodeEOX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Cytosponge Cell Collection Device is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2018-08-16 under approval number K181020. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytosponge Cell Collection Device?

Cytosponge Cell Collection Device is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Covidien, LLC. The 510(k) number is K181020.

When was Cytosponge Cell Collection Device approved by the FDA?

Cytosponge Cell Collection Device received FDA 510(k) clearance on 2018-08-16, under approval number K181020.

What company makes Cytosponge Cell Collection Device?

Cytosponge Cell Collection Device is manufactured by Covidien, LLC.

What is the FDA product code for Cytosponge Cell Collection Device?

The FDA product code for Cytosponge Cell Collection Device is EOX.

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Related Devices (Code: EOX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.