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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 implanted tibial electrical urinary continence device
De Novo Number DEN220073
Device Name Revi System
Requester
bluewind medical ltd.
6 maskit street
herzliya,  IL 4614002
Contact roni diaz
Regulation Number876.5305
Classification Product Code
QXM  
Date Received10/05/2022
Decision Date 08/16/2023
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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