FDA 510(k) Application Details - K250701

Device Classification Name	More FDA Info for this Device
510(K) Number	K250701
Device Name	Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Shinichiro Kawachi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2025
Decision Date	06/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review