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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 K230339
Device Name EsoCheck Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
360 Madison Ave., Floor 25
New York,  NY  10017
Applicant Contact Deepika Lakhani
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number874.4710
Classification Product Code
EOX  
Date Received02/07/2023
Decision Date 02/24/2023
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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