StimTrial Neuromodulation System— 510(k) K253877
Substantially EquivalentBioventus, LLC
FDA 510(k) clearance K253877 for StimTrial Neuromodulation System, Substantially Equivalent on 2026-08-26. Applicant: Bioventus, LLC. Device class: 2.
Summary
Bioventus filed the StimTrial Neuromodulation System under product code GZF, implanted peripheral nerve stimulators for pain relief. The record doesn't describe the system beyond its name and that code.
Class II, 21 CFR 882.5870. Neurology is both the classification panel and the review panel. It came in as a Special 510(k).
Bioventus filed from Durham, North Carolina. The decision came 265 calendar days after FDA received it (December 4, 2025 to August 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Bioventus, LLC
- Product code
- Product code GZF
- Device class
- Class 2
- Regulation
- 21 CFR 882.5870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Durham, NC, US
Recent devices under product code GZF
view allMore clearances from Bioventus, LLC
view allAdverse events under product code GZF
product code GZF- Death
- 10
- Injury
- 2,410
- Other
- 1
- Total
- 2,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.