FDA cleared 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 from Covidien, LLC on Sep 25, 2025 under K243785, a traditional 510(k). The device falls under product code BTR, Tube, Tracheal (W/Wo Connector), regulated at 21 CFR 868.5730 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Dec 9, 2024. The decision came 290 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).