Cleared Traditional

TRACOE silcosoft Tracheostomy Tube

K172720 · Tracoe Medical GmbH · Anesthesiology
Apr 2018
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K172720 is an FDA 510(k) clearance for the TRACOE silcosoft Tracheostomy Tube, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on April 27, 2018, 231 days after receiving the submission on September 8, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K172720 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2017
Decision Date April 27, 2018
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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