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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 K212458
Device Name Flexible Video-Uretero-Renoscope SSU System
Applicant
KARL STORZ Endoscopy America
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Mario Trujillo
Correspondent
KARL STORZ Endoscopy America
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Mario Trujillo
Regulation Number876.1500
Classification Product Code
FGB  
Date Received08/05/2021
Decision Date 01/20/2022
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
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