Cleared Traditional

TRACOE vario

K203362 · Tracoe Medical GmbH · Anesthesiology
Aug 2021
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K203362 is an FDA 510(k) clearance for the TRACOE vario, 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 August 5, 2021, 262 days after receiving the submission on November 16, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K203362 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2020
Decision Date August 05, 2021
Days to Decision 262 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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