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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 K180146
Device Name KARL STORZ ICG Imaging System
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact Winkie Wong
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
OWN  
Date Received01/18/2018
Decision Date 04/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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