Cleared Traditional

SPRINT PNS System

K202660 · Spr Therapeutics, Inc. · Neurology
Jan 2021
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K202660 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 January 22, 2021, 130 days after receiving the submission on September 14, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K202660 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2020
Decision Date January 22, 2021
Days to Decision 130 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,