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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 K183188
Device Name Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Applicant Contact Mike Loiterman
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Correspondent Contact Mike Loiterman
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Codes
FGA   ODC  
Date Received11/19/2018
Decision Date 05/03/2019
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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