Cleared Traditional

SPRINT PNS System

K211801 · Spr Therapeutics, Inc. · Neurology
Oct 2021
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K211801 is an FDA 510(k) clearance for the SPRINT PNS System, a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II — Special Controls, product code NHI), submitted by Spr Therapeutics, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 13, 2021, 125 days after receiving the submission on June 10, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K211801 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2021
Decision Date October 13, 2021
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NHI — Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,