SCNClass II
Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
21 CFR 882.5870 / Neurology
SCN is the FDA product code for Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief, a class II device type, regulated under 21 CFR 882.5870. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SCN
- Device name
- Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
- FDA 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.
- Regulation
- 21 CFR 882.5870
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SCN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SCN| Applicant | Clearances |
|---|---|
| SPR Therapeutics, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.