FDA 510(k) Application Details - K250204

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K250204
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	Shenzhen Sophway Technology Co., Ltd. A1301A,Bldg 1,Meixun Digital Technology Factory,No. 19Jinxiu Middle Rd, Laokeng Community, Longtian St, Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Peter Ye 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	01/24/2025
Decision Date	07/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review