FDA 510(k) Application Details - K212202

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K212202
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	OTU Medical INC. 2231 A Fortune Drive San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Geping Liu Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2021
Decision Date	04/13/2022
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