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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Bronchoscope
510(k) Number K260401
Device Name EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 92-8507
Applicant Contact Toshio Nakamura
Correspondent
Olympus Surgical Technologies of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Wendy Perreault
Regulation Number892.1550
Classification Product Code
PSV  
Subsequent Product Code
ITX  
Date Received02/06/2026
Decision Date 08/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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