Cleared Traditional

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

K193077 · Covidien · Anesthesiology
Jun 2020
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K193077 is an FDA 510(k) clearance for the Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on June 1, 2020, 209 days after receiving the submission on November 5, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K193077 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2019
Decision Date June 01, 2020
Days to Decision 209 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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