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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Control, Steerable
510(k) Number K243789
Device Name LIBERTY Endovascular Robotic System (LIBERTYOS)
Applicant
Microbot Medical , Ltd.
6 Hayozma St.
Yokneam,  IL 2069815
Applicant Contact Noa Ofer
Correspondent
Hogan Lovells
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number870.1290
Classification Product Code
DXX  
Date Received12/09/2024
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06141694
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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