Cleared Special

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

K233292 · Inomed Medizintechnik GmbH · Neurology
Oct 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K233292 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 October 27, 2023, 28 days after receiving the submission on September 29, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K233292 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date October 27, 2023
Days to Decision 28 days
Submission Type Special
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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