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

    GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

    K Number: K083471 · Decision Mar 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    99

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    Basic Information

    Device Name
    GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
    K Number
    K083471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Generic Medical Device, Inc.
    Date Received
    November 24, 2008
    Decision Date
    March 3, 2009
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Generic Medical Device, Inc.

    K Number Device Name
    K111219 GMD UNIVERSAL URINARY INCONTINENCE SLING
    K070018 UNIVERSAL SURGICAL MESH, MODEL 100
    K063429 GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200