FDA 510(k) Application Details - K241005

Device Classification Name	More FDA Info for this Device
510(K) Number	K241005
Device Name	Haemostasis Clips
Applicant	Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. 14th Industrial Building, Xiajiang Industrial Zone Xiajiang Ji'an 343000 CN Other 510(k) Applications for this Company
Contact	Qin Xu 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	04/12/2024
Decision Date	01/02/2025
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