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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 K251867
Device Name EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Surgical Technologies of the Americas
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Susan Lewandowski
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Codes
FEB   NWB  
Date Received06/17/2025
Decision Date 09/19/2025
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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