BEUDAMED
    Product Code: JYC FDA class 1 21 CFR 878.4800

    Cannula, Ear

    General, Plastic Surgery

    Cannula, Ear is a small tubular instrument used during ear procedures to irrigate, suction, or introduce fluids into the ear canal or middle ear space, supporting a range of otological diagnostic and therapeutic interventions. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYC, regulated under 21 CFR 878.4800, and falls within the General, Plastic Surgery medical specialty.

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    510(k)s
    2
    FEI Numbers
    50
    Registration Numbers
    50
    Unique Applicants
    2
    Years Active
    11

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    Basic Information

    Product Code
    JYC
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K891269 MICROTRAK EIA AUTOWASHER
    K780153 HOUSE SUCTION IRRIGATOR

    FEI Numbers

    This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.