AquaBeam Robotic System

Fluid Jet Removal System

PROCEPT BioRobotics Corporation

The following data is part of a premarket notification filed by Procept Biorobotics Corporation with the FDA for Aquabeam Robotic System.

Pre-market Notification Details

Device IDK212835
510k NumberK212835
Device Name:AquaBeam Robotic System
ClassificationFluid Jet Removal System
Applicant PROCEPT BioRobotics Corporation 900 Island Drive, Suite 101 Redwood City,  CA  94065
ContactSara Muddell
CorrespondentSara Muddell
PROCEPT BioRobotics Corporation 900 Island Drive, Suite 101 Redwood City,  CA  94065
Product CodePZP  
CFR Regulation Number876.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2021-10-06

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