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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 gynecologic power morcellator and containment system
De Novo Number DEN250034
Device Name Claria System
Requester
claria medical, inc.
2586 wyandotte st.
mountain view,  CA  94043
Contact brian fisher
Regulation Number884.4075
Classification Product Code
SIM  
Date Received08/07/2025
Decision Date 07/02/2026
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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