BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Cypris eXact Suture Placement Device

    K Number: K240185 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    71
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    Cypris eXact Suture Placement Device
    K Number
    K240185
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cypris Medical
    Date Received
    January 23, 2024
    Decision Date
    May 3, 2024
    Product Code
    GEJ
    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
    GEJ Carrier, Ligature

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    Other Clearances by Cypris Medical

    K Number Device Name
    K233355 Cypris eXact Suturing System