BEUDAMED
    Product Code: KAJ FDA class 1 21 CFR 874.4420

    Mobilizer, Ent

    Ear, Nose, Throat

    An ENT mobilizer is a hand instrument used during ear, nose, and throat surgical procedures to gently move, loosen, or reposition ossicular structures, tissue, or other small anatomical elements. It is classified as an FDA Class 1 device, indicating low risk, and is subject only to general controls without requiring premarket notification. Product code KAJ 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
    27
    Registration Numbers
    27
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KAJ
    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 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.