BEUDAMED
    Product Code: KLZ FDA class 2 21 CFR 874.3850

    Tube, Shunt, Endolymphatic With Valve

    Ear, Nose, Throat

    The Endolymphatic Shunt Tube with Valve is a surgically implanted device used in the treatment of Meniere's disease and endolymphatic hydrops, designed to drain excess endolymphatic fluid from the inner ear to reduce episodes of vertigo, hearing loss, and tinnitus. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLZ and it is regulated under 21 CFR 874.3850 in the Ear, Nose, and Throat specialty. This device is an implant.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KLZ
    Device Class
    FDA class 2
    Regulation Number
    874.3850
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    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
    K972383 EASY-JET DEVICE