BEUDAMED
    Product Code: JZA FDA class 1 21 CFR 874.4420

    Rongeur, Mastoid

    Ear, Nose, Throat

    Rongeur, Mastoid is a surgical biting instrument with a strong cup-shaped jaw used to remove and bite away bone tissue from the mastoid process during mastoidectomy or other temporal bone procedures, allowing access to diseased areas. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZA, 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
    33
    Registration Numbers
    33
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JZA
    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
    K822007 BONE RONGEUNS ENT & RELATED ITEMS

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.