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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K070420
FOIA Releasable 510(k) K070420
Device Name BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact MICHAEL WOLF
Correspondent
Bsi Healthcare
Kitemark Court, Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN HOWLETT
Regulation Number876.1500
Classification Product Code
ODD  
Date Received02/20/2007
Decision Date 03/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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