Cleared Traditional

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

K163355 · Ad-Tech Medical Instrument Corporation · Neurology
Apr 2017
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K163355 is an FDA 510(k) clearance for the Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Ad-Tech Medical Instrument Corporation (Racine, US). The FDA issued a Cleared decision on April 12, 2017, 133 days after receiving the submission on November 30, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K163355 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2016
Decision Date April 12, 2017
Days to Decision 133 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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