FDA 510(k) Application Details - K232200

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K232200
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Ningbo Xinwell Medical Technology Co., Ltd No.188 Binjiang Road, Cixi High-tech Industrial Development Zone Cixi 315301 CN Other 510(k) Applications for this Company
Contact	Lei Xi 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	07/25/2023
Decision Date	04/12/2024
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