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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 fluid jet removal system
De Novo Number DEN170024
Device Name AQUABEAM System
PROCEPT BioRobotics Corporation
900 island drive suite 101
redwood shores,  CA  94568
Contact michael nketiah
Regulation Number876.4350
Classification Product Code
Date Received04/17/2017
Decision Date 12/21/2017
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct