BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AugMENTA Penile Implant

    K Number: K200073 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    990

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    Basic Information

    Device Name
    AugMENTA Penile Implant
    K Number
    K200073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Augmenta, LLC
    Date Received
    January 14, 2020
    Decision Date
    September 30, 2022
    Product Code
    MIB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIB Elastomer, Silicone Block

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