BEUDAMED
    Product Code: JYE FDA class 1 21 CFR 874.4420

    Chisel, Middle-Ear

    Ear, Nose, Throat

    Chisel, Middle-Ear is a fine surgical instrument used during middle ear surgery to remove or shape small areas of bone within the middle ear space, such as during tympanoplasty, ossiculoplasty, or repair of the bony ear canal wall. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYE, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    JYE
    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
    K822165 ENT CHISELS

    FEI Numbers

    This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.