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

    DIAPHRAGMATIC HERNIA GRAFT

    K Number: K133011 · Decision Jun 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    31
    Review Days
    268

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    Basic Information

    Device Name
    DIAPHRAGMATIC HERNIA GRAFT
    K Number
    K133011
    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
    Cook Biotech, Inc.
    Date Received
    September 25, 2013
    Decision Date
    June 20, 2014
    Product Code
    OWV
    Advisory Committee
    General, Plastic Surgery
    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
    OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia

    Other Clearances by Cook Biotech, Inc.

    K Number Device Name
    K133306 SIS HERNIA GRAFT
    K131015 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
    K111695 HYBRID GRAFT
    K110402 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
    K090688 COOK UROLOGICAL GRAFT
    K082682 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
    K082058 DYNAMATRIX
    K073391 SURGISIS BIODESIGN TISSUE GRAFT
    K070405 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
    K070738 SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
    Search all 31 clearances from Cook Biotech, Inc. →