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The Tracker / August 2026 / K253877

510(k) cleared

StimTrial Neuromodulation System

Bioventus, LLC · Aug 26, 2026 · K253877

FDA cleared the StimTrial Neuromodulation System from Bioventus, LLC on Aug 26, 2026 under K253877, a special 510(k). The device falls under product code GZF, Stimulator, Peripheral Nerve, Implanted (Pain Relief), regulated at 21 CFR 882.5870 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 4, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bioventus, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253877?

K253877 is the FDA 510(k) for StimTrial Neuromodulation System, submitted by Bioventus, LLC. FDA's decision date was Aug 26, 2026, under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)).

Who makes the StimTrial Neuromodulation System?

Bioventus, LLC, based in Durham, NC, is the applicant of record for K253877.

How long did the K253877 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Aug 26, 2026, 265 days later.

← All decisions in August 2026