FDA 510(k) Application Details - K231118

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K231118
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	Shenzhen HugeMed Medical Technical Development Co., Ltd. 415,416-1,516-1, Building 2, No. 1, Mawu Road Baoan Community, Yuanshan Street, Longgang Dis Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Jiang Yuanning 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	04/20/2023
Decision Date	11/13/2023
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