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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K123421
Device Name OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received11/06/2012
Decision Date 04/29/2013
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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