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

    V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

    K Number: K082662 · Decision Mar 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    195

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    Basic Information

    Device Name
    V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
    K Number
    K082662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Devices, Tyco Healthcare Group LP
    Date Received
    September 12, 2008
    Decision Date
    March 26, 2009
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Surgical Devices, Tyco Healthcare Group LP

    K Number Device Name
    K091087 MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE