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

    TI CLIP APPLIER

    K Number: K034029 · Decision Mar 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    TI CLIP APPLIER
    K Number
    K034029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrx, LLC
    Date Received
    December 29, 2003
    Decision Date
    March 5, 2004
    Product Code
    NJC
    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
    NJC Clip, Vas Deferens

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NJC), ordered by most recent decision date.

    VASCLIP

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    K Number Device Name
    K033161 VISU-LOCK 5MM CLIP APPLIER