FDA 510(k) Application Details - K211858

Device Classification Name	More FDA Info for this Device
510(K) Number	K211858
Device Name	TULSA-PRO System
Applicant	Profound Medical Inc. 2400 Skymark Avenue Unit #6 Mississauga L4W 5K5 CA Other 510(k) Applications for this Company
Contact	Goldy Singh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2021
Decision Date	09/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review