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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K243562
Device Name CuffGuard
Applicant
Idmed
3 Rue John Maynard Keynes
Marseille,  FR 13013
Applicant Contact Aurelie Gruener
Correspondent
Idmed
3 Rue John Maynard Keynes
Marseille,  FR 13013
Correspondent Contact Perrine Moelle
Regulation Number868.5750
Classification Product Code
BSK  
Date Received11/18/2024
Decision Date 08/12/2025
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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