FDA 510(k) Application Details - K240200

Device Classification Name	More FDA Info for this Device
510(K) Number	K240200
Device Name	HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Applicant	Procept BioRobotics 150 Baytech Drive San Jose, CA 95134 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	01/25/2024
Decision Date	08/20/2024
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