FDA 510(k) Application Details - K243321

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K243321
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	Guangzhou Red Pine Medical Instrument Co., Ltd. 12 F, No.87 Luoxuan Avenue Guangzhou International Bioisland, Huangpu District Guangzhou 510000 CN Other 510(k) Applications for this Company
Contact	Weihua Wang Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2024
Decision Date	02/07/2025
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