FDA 510(k) Application Details - K220587

Device Classification Name	Duodenoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K220587
Device Name	Duodenoscope And Accessories, Flexible/Rigid
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshio Nakamura Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2022
Decision Date	05/11/2022
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