FDA 510(k) Application Details - K231721

Device Classification Name	Forceps, Biopsy, Electric   More FDA Info for this Device
510(K) Number	K231721
Device Name	Forceps, Biopsy, Electric
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	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2023
Decision Date	12/14/2023
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