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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K262406
Device Name EluPro Antibiotic-Eluting BioEnvelope
Applicant
Boston Scientific
4100 Hamline Ave. N.
Saint Paul,  MN  55112
Applicant Contact Cary Percy
Correspondent
Boston Scientific
4100 Hamline Ave. N.
Saint Paul,  MN  55112
Correspondent Contact Cary Percy
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
FTL   OXH   PIJ  
Date Received07/15/2026
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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