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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K222366
Device Name EsoCheck Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
One Grand Central Pl., Suite 4600
New York,  NY  10165
Applicant Contact Lishan Aklog
Correspondent
Hogan Lovells US Lpp
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number874.4710
Classification Product Code
EOX  
Date Received08/04/2022
Decision Date 10/26/2022
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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