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FDA 510(k)

EsoCheck Cell Collection Device

K-Number: K230339 · 2023-02-24

ApplicantLucid Diagnostics, Inc.
Decision Date2023-02-24
Product CodeEOX
Advisory CommitteeEN
DecisionUnknown

Device Summary

EsoCheck Cell Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Lucid Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K230339. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EsoCheck Cell Collection Device?

EsoCheck Cell Collection Device is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Lucid Diagnostics, Inc.. The 510(k) number is K230339.

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

EsoCheck Cell Collection Device received FDA 510(k) clearance on 2023-02-24, under 510(k) number K230339.

Who is the listed applicant for EsoCheck Cell Collection Device?

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

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

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

Other records listing Lucid Diagnostics, Inc. as applicant

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.

K222366EsoCheck Cell Collection DeviceK210137EsoCheck Cell Collection DeviceK183262EsoCheck CCD Cell Collection Device

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 LimitedK223072PENTAX 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.K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG

Official Source

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