FDA 510(k) Application Details - K250452

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K250452
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	MacroLux Medical Technology Co., Ltd. 301, Building 3, NamTai Inno Park In Guang Ming Avenue Guangming Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Ye Linbin Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2025
Decision Date	06/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review