FDA 510(k) Application Details - K213223

Device Classification Name	Ligator, Hemorrhoidal   More FDA Info for this Device
510(K) Number	K213223
Device Name	Ligator, Hemorrhoidal
Applicant	Beijing ZKSK Technology Co.,Ltd Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzho Beijing 101105 CN Other 510(k) Applications for this Company
Contact	Ma Li Other 510(k) Applications for this Contact
Regulation Number	876.4400   More FDA Info for this Regulation Number
Classification Product Code	FHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	06/06/2022
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