FDA 510(k) Application Details - K220292

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K220292
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Yangzhou Fartley Medical Instrument Technology Co., Ltd. Beizhou Road, Lidian Town, Guangling District Yangzhou 225106 CN Other 510(k) Applications for this Company
Contact	Tina Han Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2022
Decision Date	08/19/2022
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