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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K252341
Device Name EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi
Tokyo,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Teffany Hutto
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
NWB  
Date Received07/28/2025
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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