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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 K223097
Device Name RenaNav Ureteroscope System
Applicant
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Applicant Contact Marybeth Gamber
Correspondent
CenterPoint Systems, LLC
3338 Pkwy. Blvd.
West Valley City,  UT  84119
Correspondent Contact Marybeth Gamber
Regulation Number876.1500
Classification Product Code
FGB  
Date Received09/30/2022
Decision Date 07/31/2023
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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