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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K261183
Device Name EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
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 Deborah Kipp
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received04/10/2026
Decision Date 07/31/2026
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
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