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FDA 510(k)

Cytosponge Cell Collection Device

K-Number: K152794 · 2016-04-12

ApplicantCovidien, LLC
Decision Date2016-04-12
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cytosponge Cell Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K152794. 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 2016-04-12. The listed applicant is Covidien, LLC. The 510(k) number is K152794.

When did Cytosponge Cell Collection Device receive FDA 510(k) clearance?

Cytosponge Cell Collection Device received FDA 510(k) clearance on 2016-04-12, under 510(k) number K152794.

Who is the listed applicant for Cytosponge Cell Collection Device?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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NCT06071845Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal SamplesRECRUITING

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Related Devices (Code: EOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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.

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