FDA 510(k) Application Details - K234124

Device Classification Name	More FDA Info for this Device
510(K) Number	K234124
Device Name	Single Use Hemoclips
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	Zearou Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2023
Decision Date	07/12/2024
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