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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mediastinoscope, Surgical
510(k) Number K260003
Device Name KARL STORZ Mediastinoscopes and Instruments
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Applicant Contact Jordan Lydia Verla
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Correspondent Contact Jordan Lydia Verla
Regulation Number874.4720
Classification Product Code
EWY  
Date Received01/02/2026
Decision Date 03/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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