FDA product code SCN: Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
SCN is the FDA product code for temporarily implanted peripheral nerve stimulation system for sustained pain relief. It is a Class II device, regulated under 21 CFR 882.5870 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SCN, 1 in the last five years. The average 510(k) review took 734 days (median 734); 734 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5870 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SCN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 734 |
Compare with all 510(k) review times · Search every SCN clearance
Top SCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spr Therapeutics, Inc. | 1 | 2026-04-14 |
Most recent SCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240974 | Spr Therapeutics, Inc. | SPRINT PNS System | 2026-04-14 | 734 |
Recalls for SCN devices
openFDA lists no recalls for product code SCN.
Frequently asked questions
What is FDA product code SCN?
SCN is the FDA product code for temporarily implanted peripheral nerve stimulation system for sustained pain relief. It is a Class II device, regulated under 21 CFR 882.5870 and reviewed by the Neurology panel.
What device class is SCN?
Class II, regulation 21 CFR 882.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCN?
Across 1 cleared submissions the average was 734 days from receipt to decision (median 734).
Which companies have the most SCN clearances?
Spr Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCN
- Run a recall and safety report across every SCN manufacturer
- Watch product code SCN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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