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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K243785
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
Applicant
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Shruti Shah
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Shruti Shah
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/09/2024
Decision Date 09/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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