Cleared Traditional

Shiley Neonatal/Pediatric Tracheostomy Tube

K182861 · Covidien · Anesthesiology
Mar 2019
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K182861 is an FDA 510(k) clearance for the Shiley Neonatal/Pediatric Tracheostomy Tube, 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 March 22, 2019, 162 days after receiving the submission on October 11, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K182861 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2018
Decision Date March 22, 2019
Days to Decision 162 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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