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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 K252703
Device Name LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
Applicant
Boston Scientific Corporation
Boston Scientific Corporation -Urology And Pelvic Health
Division
Marlborough,  MA  01752
Applicant Contact Alexandra Skinner
Correspondent
Boston Scientific Corporation
Boston Scientific Corporation -Urology And Pelvic Health
Division
Marlborough,  MA  01752
Correspondent Contact Alexandra Skinner
Regulation Number876.1500
Classification Product Code
FGB  
Date Received08/27/2025
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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