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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 K233372
Device Name KARL STORZ Fiber Telescopes for Urology
Applicant
Karl Storz SE & Co.Kg
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Applicant Contact Alita McElroy
Correspondent
Karl Storz Endoscopy America
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Jordan Lydia Verla
Regulation Number876.1500
Classification Product Code
FGB  
Date Received10/02/2023
Decision Date 07/25/2024
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
Recalls CDRH Recalls
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