510(k) Report

FDA product code · Neurology

Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief

SCNClass II21 CFR 882.5870510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of SCN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — SCN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SCN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 882.5870.