FDA 510(k) Application Details - K232442

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K232442
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Zhejiang Soudon Medical Technology Co.,Ltd Room 302-1, Floor 3, Building 4, No.1 Nangonghe Road, Donghu Street, Linping District Hangzhou 311100 CN Other 510(k) Applications for this Company
Contact	Junshi Wang 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	08/14/2023
Decision Date	11/09/2023
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