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

    Digitex Delivery Device

    K Number: K173527 · Decision Feb 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    71
    Review Days
    90

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    Basic Information

    Device Name
    Digitex Delivery Device
    K Number
    K173527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4910
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast A/S
    Date Received
    November 14, 2017
    Decision Date
    February 12, 2018
    Product Code
    PWI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

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