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

    PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS

    K Number: DEN110016 · Decision Apr 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    222

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    Basic Information

    Device Name
    PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
    K Number
    DEN110016
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4805
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Ethicon Endo-Surgery
    Date Received
    September 21, 2011
    Decision Date
    April 30, 2012
    Product Code
    OXT
    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
    OXT Percutaneous Surgical Set With Attachments

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