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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K131953
Device Name IMAGE1 SPIES
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact WINKIE WONG
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact WINKIE WONG
Regulation Number876.1500
Classification Product Code
FET  
Date Received06/27/2013
Decision Date 12/20/2013
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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