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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K123601
Device Name SINGLE USE REPOSITIONABLE CLIP
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact SHERI L MUSGNUNG
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Parkway
Center Valley,  PA  18034 -0610
Correspondent Contact Steven L Keenan
Regulation Number876.4400
Classification Product Code
PKL  
Date Received11/21/2012
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
Recalls CDRH Recalls
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