Cleared Special

Guardian Needle Electrode

K200984 · Rhythmlink International, LLC · Neurology
May 2020
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K200984 is an FDA 510(k) clearance for the Guardian Needle Electrode, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on May 27, 2020, 43 days after receiving the submission on April 14, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K200984 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2020
Decision Date May 27, 2020
Days to Decision 43 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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