BEUDAMED
    Product Code: KAY FDA class 1 21 CFR 874.4420

    Punch, Nasal

    Ear, Nose, Throat

    A nasal punch is a surgical instrument used to create or enlarge openings in nasal cartilage or bone during reconstructive or functional nasal procedures, allowing precise removal of small tissue or cartilage fragments. 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 KAY 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
    55
    Registration Numbers
    55
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KAY
    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 55 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.