Cleared Traditional

Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced

K243785 · Covidien, LLC · Anesthesiology
Sep 2025
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K243785 is an FDA 510(k) clearance for the Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced, 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 September 25, 2025, 290 days after receiving the submission on December 9, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K243785 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2024
Decision Date September 25, 2025
Days to Decision 290 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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