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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Modular Electromechanical Surgical System
510(k) Number K260804
Device Name Anovo Surgical System (6Ne)
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
Classification Product Code
SCV  
Date Received03/12/2026
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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