BEUDAMED
    Product Code: JYZ FDA class 1 21 CFR 874.4420

    Rod, Measuring Ear

    Ear, Nose, Throat

    Rod, Measuring Ear is a calibrated surgical rod used to measure distances or depths within the ear canal or middle ear space during ENT surgical procedures, enabling accurate sizing of prostheses or implants to be placed. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYZ, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

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    510(k)s
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JYZ
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K781500 MODEL 845T IMAGING/ERGOMETER TABLE

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.