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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K232997
Device Name EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho,
Hachioji-Shi
Tokyo,  JP
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Darlene R Hull
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
NWB  
Date Received09/22/2023
Decision Date 06/19/2024
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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