FDA 510(k) Premarket Notification K243785: 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

Submission Details & Decision

Normalized public record details for 510(k) notification K243785.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243785

Applicant / Sponsor

Covidien, LLC

Device Name

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

Product Code

BTR

Decision Date

2025-09-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-12-09

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