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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 K243532
Device Name LumiRex Ureteroscope
Applicant
Contra Healthcare Solutions, LLC
105 Lincoln Ave.
Butler,  PA  16001
Applicant Contact John O'Conner
Correspondent
Contra Healthcare Solutions, LLC
105 Lincoln Ave.
Butler,  PA  16001
Correspondent Contact John O'Connor
Regulation Number876.1500
Classification Product Code
FGB  
Date Received11/15/2024
Decision Date 04/28/2025
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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