FDA 510(k) Application Details - K202961

Device Classification Name	More FDA Info for this Device
510(K) Number	K202961
Device Name	AquaBeam Robotic System
Applicant	PROCEPT BioRobotics Corporation 900 Island Drive, Suite 101 Redwood City, CA 94065 US Other 510(k) Applications for this Company
Contact	Sara Muddell 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	09/30/2020
Decision Date	03/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review