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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K253877
Device Name StimTrial Neuromodulation System
Applicant
Bioventus, LLC
4721 Emperor Blvd., Suite 100
Durham,  NC  27703
Applicant Contact Sageev George
Correspondent
Bioventus, LLC
4721 Emperor Blvd., Suite 100
Durham,  NC  27703
Correspondent Contact Sageev George
Regulation Number882.5870
Classification Product Code
GZF  
Date Received12/04/2025
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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