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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K142922
FOIA Releasable 510(k) K142922
Device Name SpyGlass DS Direct Visualization System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact CARTER NAVARRO
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact CARTER NAVARRO
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
KQM   NTN  
Date Received10/08/2014
Decision Date 01/16/2015
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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