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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K261260
Device Name HD Camera Head OLYMPUS CH-S200-08-LB
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Eve Smith
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
NWB  
Date Received04/16/2026
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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