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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 injectable for thermal treatment of musculoskeletal pain
De Novo Number DEN250067
Device Name ReneuRx™ (Neural Ice)
Requester
brixton biosciences
1000 massachusetts ave.
suite 101
cambridge,  MA  02138
Contact olivier kagan
Regulation Number888.3048
Classification Product Code
SJA  
Date Received12/15/2025
Decision Date 08/21/2026
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Direct
Predetermined Change
Control Plan Authorized		 No
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