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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 integrated operating table-electromechanical surgical system
De Novo Number DEN250068
Device Name OTTAVA™ Robotic Surgical System
Requester
auris health, inc., part of johnson & johnson medtech
5490 great american pkwy.
santa clara,  CA  95054
Contact anna (inna) libman
Regulation Number878.4966
Classification Product Code
SIR  
Date Received12/18/2025
Decision Date 07/21/2026
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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