510(k) K243782
K243782 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 July 16, 2025. 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 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2025
- Date Received
- December 9, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5870
- Review Panel
- NE
- Submission Type