FDA 510(k) Application Details - K240675

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K240675
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City 311121 CN Other 510(k) Applications for this Company
Contact	Yang Zearou 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	03/11/2024
Decision Date	10/04/2024
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