FDA 510(k) Application Details - K243857

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K243857
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Shanghai AnQing Medical Instrument Co., Ltd. 3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East Zhangjiang High-Tech Park Shanghai 201201 CN Other 510(k) Applications for this Company
Contact	Shuwen Fan 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	12/16/2024
Decision Date	04/11/2025
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