Cleared Traditional

Myoject Luer Lock Needle Electrode

K161430 · Natus Manufacturing Limited · Neurology
Mar 2017
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K161430 is an FDA 510(k) clearance for the Myoject Luer Lock Needle Electrode, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Natus Manufacturing Limited (Gort, IE). The FDA issued a Cleared decision on March 2, 2017, 283 days after receiving the submission on May 23, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K161430 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2016
Decision Date March 02, 2017
Days to Decision 283 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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