FDA 510(k) Application Details - DEN170024

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170024
Device Name	AQUABEAM System
Applicant	PROCEPT BioRobotics Corporation 900 Island Drive Suite 101 Redwood Shores, CA 94568 US Other 510(k) Applications for this Company
Contact	Michael Nketiah Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2017
Decision Date	12/21/2017
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review