Cleared Special

TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

K111131 · Carefusion 209, Inc. · Neurology
Jun 2011
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K111131 is an FDA 510(k) clearance for the TECA (TM) ELITE DISPOSABLE MONOPOLAR 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 June 17, 2011, 57 days after receiving the submission on April 21, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K111131 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2011
Decision Date June 17, 2011
Days to Decision 57 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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