FDA 510(k) Application Details - K172120

Device Classification Name	Pneumoperitoneum Needle   More FDA Info for this Device
510(K) Number	K172120
Device Name	Pneumoperitoneum Needle
Applicant	WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Wang Street, Lilin Town, Zhongkai Hi-Tech Zone Huizhou 516000 CN Other 510(k) Applications for this Company
Contact	Haobin Li Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2017
Decision Date	09/14/2017
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