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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mountable Electromechanical Surgical System For Transluminal Approaches
510(k) Number K241907
Device Name Anovo Surgical System (model 6N)
Applicant
Momentis Surgical , Ltd.
6 Yoni Netanyahu St.
Or Yehuda,  IL 6037604
Applicant Contact Maya Leib Shlomo
Correspondent
Momentis Surgical , Ltd.
6 Yoni Netanyahu St.
Or Yehuda,  IL 6037604
Correspondent Contact Maya Leib Shlomo
Regulation Number878.4961
Classification Product Code
QNM  
Date Received07/01/2024
Decision Date 10/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT06457971
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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