FDA 510(k) Application Details - K233778

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K233778
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Zhuhai Pusen Medical Technology Co., Ltd. 5/F, Building 1, No. 33, Ke Ji San Road, High-tech zone, TangJiaWan Town Zhuhai 519000 CN Other 510(k) Applications for this Company
Contact	Changshen Wang Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2023
Decision Date	07/16/2024
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