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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrogel Spacer
510(k) Number K260119
Device Name SpaceOAR Vue System (SV-2101)
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Cassidy Yeomans
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Cassidy Yeomans
Regulation Number892.5725
Classification Product Code
OVB  
Date Received01/14/2026
Decision Date 02/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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