BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES

    K Number: K072951 · Decision Dec 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    30
    Applicant Total
    42
    Review Days
    62

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    Basic Information

    Device Name
    PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
    K Number
    K072951
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    884.5980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sofradim Production
    Date Received
    October 18, 2007
    Decision Date
    December 19, 2007
    Product Code
    OTP
    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
    OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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    Other Clearances by Sofradim Production

    K Number Device Name
    K253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
    K250869 Parietene™ Macroporous Mesh (PPM5050 )
    K243315 ProGrip™ Self-Gripping Polypropylene Mesh
    K233661 Transorb™ Self-Gripping Resorbable Mesh
    K232373 Progrip™ Self-Gripping Polypropylene Mesh
    K223218 Parietene Macroporous Mesh
    K220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
    K192443 Dextile Anatomical Mesh
    K173796 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
    K172395 Duatene bilayer mesh
    Search all 42 clearances from Sofradim Production →