510(k) K253877

StimTrial Neuromodulation System by Bioventus, LLC — Product Code GZF

K253877 is an FDA 510(k) premarket notification submitted by Bioventus, LLC for the device "StimTrial Neuromodulation System". The FDA issued a decision of Substantially Equivalent on August 26, 2026. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Bioventus, LLC has at least 6 other 510(k) clearances on record.