Cleared Traditional

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

K212166 · Inomed Medizintechnik GmbH · Neurology
Jan 2022
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K212166 is an FDA 510(k) clearance for the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on January 7, 2022, 179 days after receiving the submission on July 12, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K212166 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2021
Decision Date January 07, 2022
Days to Decision 179 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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