DeviceClearance

Product code SCN— Neurology

SPRINT PNS System

Classification name
Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
Device class
Class 2
Regulation
21 CFR 882.5870
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SCN under 21 CFR 882.5870, via openFDA

Market context for product code SCN

FDA has cleared 1 device under product code SCN, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SCN

Recent clearances under product code SCN

Data sourced from openFDA. This site is unofficial and independent of the FDA.