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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K183112
Device Name DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
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 Number878.4400
Classification Product Code
GEI  
Date Received11/08/2018
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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