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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 K260581
Device Name KARL STORZ Flexible Video Neuro-Endoscope
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Applicant Contact Emily Rhiel
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Correspondent Contact Emily Rhiel
Regulation Number882.1480
Classification Product Code
GWG  
Date Received02/20/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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