FDA 510(k) Application Details - K241444

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K241444
Device Name	Choledochoscope And Accessories, Flexible/Rigid
Applicant	Shenzhen HugeMed Medical Technical Development Co., Ltd. 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17 Bulan Road,Xialilang Community, Nanwan Street, Longgang Dist Shenzhen 518112 CN Other 510(k) Applications for this Company
Contact	Cathy Shi 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	05/22/2024
Decision Date	01/21/2025
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