BEUDAMED
    Product Code: JYK FDA class 1 21 CFR 878.1800

    Holder, Ear Speculum

    General, Plastic Surgery

    Holder, Ear Speculum is a surgical accessory used to retain and stabilize an ear speculum in position during examination or surgery of the ear canal, freeing the clinician's hands for examination or operative tasks. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYK, regulated under 21 CFR 878.1800, and falls within the General, Plastic Surgery medical specialty.

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    510(k)s
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JYK
    Device Class
    FDA class 1
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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
    K822011 SHEA'S EAR SPECULUM HOLDER PORT MANNS

    FEI Numbers

    This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.