FDA 510(k) Application Details - K232476

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K232476
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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	Wang Junshi Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2023
Decision Date	11/07/2023
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