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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 K261153
Device Name LithoVue Elite Digital Flexible Ureteroscope System
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Avinash Purohit
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Avinash Purohit
Regulation Number876.1500
Classification Product Code
FGB  
Date Received04/08/2026
Decision Date 08/26/2026
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		 Yes
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