Cleared Traditional

Sparrow Therapy System

K201873 · Spark Biomedical, Inc. · Neurology

Jan 2021

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K201873 is an FDA 510(k) clearance for the Sparrow Therapy System, a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II — Special Controls, product code PZR), submitted by Spark Biomedical, Inc. (Dallas, US). The FDA issued a Cleared decision on January 2, 2021, 179 days after receiving the submission on July 7, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5896.

Submission Details

510(k) Number	K201873 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2020
Decision Date	January 02, 2021
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5896
Definition	Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.