510(k) clearance
StimTrial Neuromodulation System
- 510(k) number
- K253877
- Applicant
- Bioventus, LLC
- Decision date
- Aug 26, 2026
- Date received
- Dec 4, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- GZF
- Device type
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device class
- Class II
- Regulation
- 21 CFR 882.5870
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Durham, NC, US