FDA 510(k) Application Details - K220790

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K220790
Device Name	Snare, Flexible
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	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2022
Decision Date	06/27/2022
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