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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K250584
Device Name Rezum System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Joseph Tabor
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Joseph Tabor
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/27/2025
Decision Date 06/11/2025
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		 No
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