Product Code: SCN
FDA class 2
21 CFR 882.5870
Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
Neurology
510(k)s
1
FEI Numbers
6
Registration Numbers
6
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SCN
- Device Class
- FDA class 2
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240974 | SPRINT PNS System | Apr 14, 2026 | Substantially Equivalent | Spr Therapeutics, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.