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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 K233645
Device Name StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
Applicant
Boston Scientific Corporation -
Urology And Pelvic Health Division
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Alexandra Skinner
Correspondent
Boston Scientific Corporation -
Urology And Pelvic Health Division
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Alexandra Skinner
Regulation Number876.1500
Classification Product Code
FGB  
Date Received11/14/2023
Decision Date 12/12/2023
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
Recalls CDRH Recalls
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