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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K243550
Device Name KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
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 Number876.1500
Classification Product Code
FGB  
Date Received11/15/2024
Decision Date 06/06/2025
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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