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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K160241
Device Name Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
2951 Ishikawa-cho
Hachioji-shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Daphney Germain-Kolawole
Regulation Number876.4300
Classification Product Code
Date Received02/01/2016
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No