BEUDAMED
    Product Code: KAZ FDA class 1 21 CFR 874.4420

    Rasp, Frontal-Sinus

    Ear, Nose, Throat

    A frontal-sinus rasp is a rough-surfaced surgical instrument used in ENT surgery to smooth, abrade, or reshape the bony walls of the frontal sinus during procedures aimed at improving drainage or correcting anatomical abnormalities. It is classified as an FDA Class 1 device, the lowest risk tier, requiring only general controls and no premarket notification. Product code KAZ 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
    17
    Registration Numbers
    17
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KAZ
    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 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.