FDA 510(k) Application Details - K231105

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K231105
Device Name	Choledochoscope 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	FBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2023
Decision Date	10/17/2023
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