Cleared Traditional

Allergan Botox Needle Electrode

K173815 · Natus Manufacturing Limited · Neurology
Jun 2018
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K173815 is an FDA 510(k) clearance for the Allergan Botox 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 June 29, 2018, 196 days after receiving the submission on December 15, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K173815 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2017
Decision Date June 29, 2018
Days to Decision 196 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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