BEUDAMED
    Product Code: KAC FDA class 1 21 CFR 874.4420

    Tube, Laryngectomy

    Ear, Nose, Throat

    A laryngectomy tube is a device used to maintain an open airway following surgical removal of all or part of the larynx, typically inserted into the stoma to facilitate breathing after a laryngectomy procedure. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls only and not requiring premarket clearance. Product code KAC is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

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    510(k)s
    4
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    4
    Years Active
    9

    Basic Information

    Product Code
    KAC
    Device Class
    FDA class 1
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K901377 BARTON-MAYO TRACHEOSTOMA BUTTON
    K873992 LARYNGECTOMY TUBE
    K821993 SHILEY LARYNGECTOMY TUBE
    K811428 NORTHWESTERN VOICE RESTORATION KIT

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.