FDA 510(k) Application Details - K211814

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K211814
Device Name	Endoscope Channel Accessory
Applicant	Well Lead Medical CO., LTD. No. 47 Guomao Avenue South, Hualong, Panyu Guangzhou 511434 CN Other 510(k) Applications for this Company
Contact	Caroline Gong Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2021
Decision Date	01/14/2022
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