Cleared Traditional

MADgic Laryngo-Tracheal Mucosal Atomization Device

K153470 · Teleflex Medical · Anesthesiology
Aug 2016
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K153470 is an FDA 510(k) clearance for the MADgic Laryngo-Tracheal Mucosal Atomization Device, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 19, 2016, 261 days after receiving the submission on December 2, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number K153470 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2015
Decision Date August 19, 2016
Days to Decision 261 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCT — Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5170

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