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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K182540
Device Name DiLumen Endolumenal Interventional Platform
Applicant
Lumendi, LLC
253 Post Rd. W.
Westport,  CT  06880
Applicant Contact Dennis Daniels
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.1500
Classification Product Code
FDF  
Date Received09/14/2018
Decision Date 10/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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