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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 K261499
Device Name TrachFlush
Applicant
Aw Technologies Aps
Amalienborgvej 57
Norresundby,  DK 9400
Applicant Contact Jorgen Hansen
Correspondent
Aw Technologies Aps
Amalienborgvej 57
Norresundby,  DK 9400
Correspondent Contact Jorgen Hansen
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/06/2026
Decision Date 08/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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