BEUDAMED
    Product Code: ETC FDA class 2 21 CFR 874.3430

    Mold, Middle-Ear

    Ear, Nose, Throat

    The middle-ear mold is a device placed in the middle ear cavity to maintain space and shape during healing following surgical reconstruction of middle ear structures. It is classified as FDA Class 2, representing moderate risk, and requires premarket clearance. The product code is ETC, regulated under 21 CFR 874.3430 in the Ear, Nose, Throat specialty. This device is designated as an implant.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Research product code ETC in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    ETC
    Device Class
    FDA class 2
    Regulation Number
    874.3430
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K921433 ATTIC DEFECT PLATE

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.