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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K232837
Device Name Uro-G HD Flexible Cystoscope
Applicant
UroViu Corporation
4546 El Camino Real Suite 214
Los Altos,  CA  94022
Applicant Contact Thom Lawson
Correspondent
UroViu Corporation
4546 El Camino Real Suite 214
Los Altos,  CA  94022
Correspondent Contact Thom Lawson
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received09/14/2023
Decision Date 06/07/2024
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
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