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

    Phasix ST Umbilical Hernia Patch

    K Number: K243241 · Decision Feb 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    132

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    Basic Information

    Device Name
    Phasix ST Umbilical Hernia Patch
    K Number
    K243241
    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
    Davol, Inc., A Subsidiary of C.R. Bard, Inc.
    Date Received
    October 10, 2024
    Decision Date
    February 19, 2025
    Product Code
    OWT
    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
    OWT Mesh, Surgical, Absorbable, Abdominal Hernia

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