FDA 510(k) Application Details - K242067

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K242067
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	Olympus Corporations of the Americas 800 West Park Drive Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Elizabeth Greene 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	07/15/2024
Decision Date	04/02/2025
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