Cleared Traditional

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

K181422 · Spr Therapeutics, Inc. · Neurology
Jul 2018
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K181422 is an FDA 510(k) clearance for the SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit, 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 July 31, 2018, 61 days after receiving the submission on May 31, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K181422 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2018
Decision Date July 31, 2018
Days to Decision 61 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,