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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 K262460
Device Name Rezum System
Applicant
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Yuki Yamashita
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Yuki Yamashita
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/17/2026
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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