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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K170462
Device Name KARL STORZ ShuntScope
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo,  CA  90245
Applicant Contact Susie S. Chen
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo,  CA  90245
Correspondent Contact Nozomi S. Yagi
Regulation Number882.1480
Classification Product Code
GWG  
Date Received02/15/2017
Decision Date 05/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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