Cleared Traditional

K230796 - Sparrow Ascent
(FDA 510(k) Clearance)

K230796 · Spark Biomedical, Inc. · Neurology
Jun 2023
Decision
90d
Days
Class 2
Risk

K230796 is an FDA 510(k) clearance for the Sparrow Ascent, 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 June 20, 2023, 90 days after receiving the submission on March 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5896.

Submission Details

510(k) Number K230796 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2023
Decision Date June 20, 2023
Days to Decision 90 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.