BEUDAMED
    Product Code: JZE FDA class 1 21 CFR 874.4420

    Spoon, Ear

    Ear, Nose, Throat

    Spoon, Ear is a small spoon-shaped surgical instrument used to collect, manipulate, or remove material from the ear canal or middle ear during ENT procedures, serving a function similar to a curette for gentle tissue removal or specimen collection. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZE, 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
    34
    Registration Numbers
    34
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JZE
    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
    K884483 CRUCIOMETER

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.