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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 K262151
Device Name SpaceOAR Flex™ System
Applicant
Boston Scientific Corporation
Urology
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Shirin Mate
Correspondent
Boston Scientific Corporation
Urology
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Shirin Mate
Regulation Number892.5725
Classification Product Code
OVB  
Date Received06/25/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Clinical Trials NCT06451614
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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