Cleared Traditional

SURGICAL STIMULATORS

K110422 · Technomed Europe · Ear, Nose, Throat
May 2011
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K110422 is an FDA 510(k) clearance for the SURGICAL STIMULATORS, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on May 26, 2011, 101 days after receiving the submission on February 14, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K110422 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2011
Decision Date May 26, 2011
Days to Decision 101 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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