SCN — Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief Class II
FDA product code SCN covers "Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief", a Class II medical device regulated under 21 CFR 882.5870. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SCN
- Device Class
- Class II
- Regulation Number
- 882.5870
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Definition
A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240974 | spr therapeutics | SPRINT PNS System | April 14, 2026 |