AQUABEAM System

Fluid Jet Removal System

The following data is part of a De Novo classification by Procept Biorobotics Corporation with the FDA for Aquabeam System.

DeNovo ID	DEN170024
Device Name:	AQUABEAM System
Classification	Fluid Jet Removal System
Applicant	PROCEPT BioRobotics Corporation 900 Island Drive Suite 101 Redwood Shores, CA 94568
Contact	Michael Nketiah
Product Code	PZP
CFR Regulation Number	876.4350 [🔎]
Decision	Granted (DENG)
510(k) Premarket Notification	Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory Board	Gastroenterology/Urology
Classification Advisory	General & Plastic Surgery
Type	Direct
Date Received	2017-04-17
Decision Date	2017-12-21
FDA Review	Decision Summary
Reclassification Order:	Reclassification Order