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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K254103
Device Name HOPKINS Telescopes for Arthroscopy
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 Number888.1100
Classification Product Code
HRX  
Date Received12/19/2025
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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