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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name mountable electromechanical surgical system for transluminal approaches
De Novo Number DEN190022
Device Name Hominis Surgical System
Memic Innovative Surgery Ltd.
6 yonatan netanyahu street
or yehuda,  IL 6037604
Contact einav yemini
Regulation Number878.4961
Classification Product Code
Date Received04/17/2019
Decision Date 02/26/2021
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct