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

    FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE

    K Number: K883856 · Decision Sep 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    64
    Review Days
    16

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    Basic Information

    Device Name
    FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
    K Number
    K883856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    September 13, 1988
    Decision Date
    September 29, 1988
    Product Code
    HBI
    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
    HBI Illuminator, Fiberoptic, Surgical Field

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    Other Clearances by Advanced Surgical Products, Inc.

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    K890398 RYAN-STYLE DIRECTED INFUSION MANIPULATOR
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