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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K244001
Device Name KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Applicant Contact Thomas Ostrowski
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Correspondent Contact Thomas Ostrowski
Regulation Number876.1500
Classification Product Code
FBO  
Date Received12/26/2024
Decision Date 05/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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