Cleared Traditional

LARYNGEAL ELECTRODE

K121257 · Technomed Europe · Ear, Nose, Throat
Aug 2012
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K121257 is an FDA 510(k) clearance for the LARYNGEAL ELECTRODE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on August 28, 2012, 124 days after receiving the submission on April 26, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K121257 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2012
Decision Date August 28, 2012
Days to Decision 124 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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