BEUDAMED
    Product Code: KAX FDA class 1 21 CFR 874.4420

    Punch, Ethmoid

    Ear, Nose, Throat

    An ethmoid punch is a surgical cutting instrument used in endoscopic sinus surgery to remove or enlarge tissue within the ethmoid sinuses, improving sinus drainage in patients with chronic sinusitis or polyposis. It is classified as an FDA Class 1 device, requiring only general controls and not subject to premarket notification. Product code KAX 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
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KAX
    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

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.