Cleared Traditional

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

K152984 · Bio Protech, Inc. · Neurology
Jun 2016
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K152984 is an FDA 510(k) clearance for the Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on June 3, 2016, 238 days after receiving the submission on October 9, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K152984 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2015
Decision Date June 03, 2016
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKT — Electrode, Needle, Diagnostic Electromyograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1385

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