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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 K201897
Device Name Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
vernon hills,  IL  60061
Applicant Contact michael loiterman
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
vernon hills,  IL  60061
Correspondent Contact michael loiterman
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/08/2020
Decision Date 01/15/2021
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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