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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K220587
Device Name Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshio Nakamura
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact Wendy Perreault
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
NWB  
Date Received03/01/2022
Decision Date 05/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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