FDA 510(k) Application Details - K243260

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K243260
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun 258-8538 JP Other 510(k) Applications for this Company
Contact	Chaitrali Kulkarni 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	10/15/2024
Decision Date	04/11/2025
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