Cleared Traditional

Shiley? Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

K233341 · Covidien, LLC · Anesthesiology
May 2024
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K233341 is an FDA 510(k) clearance for the Shiley? Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on May 20, 2024, 234 days after receiving the submission on September 29, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K233341 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date May 20, 2024
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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