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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K143153
FOIA Releasable 510(k) K143153
Device Name EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ISHIKAWA-CHO
HACHIOJI-SHI,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
OLYMPUS CORPORATION OF THE AMERICAS
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact Sheri L Musgnung
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
NWB  
Date Received11/03/2014
Decision Date 01/15/2016
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
Recalls CDRH Recalls
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