Cleared Special

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES

K112034 · Carefusion 209, Inc. · Neurology
Aug 2011
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K112034 is an FDA 510(k) clearance for the TECA ELITE DISPOSABLE CONCENTRIC NEEDLES, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Carefusion 209, Inc. (Middleton, US). The FDA issued a Cleared decision on August 12, 2011, 28 days after receiving the submission on July 15, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K112034 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2011
Decision Date August 12, 2011
Days to Decision 28 days
Submission Type Special
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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