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

    ACCURA ELITE SHUNT SYSTEM

    K Number: K024040 · Decision Jan 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    12
    Review Days
    52

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    Basic Information

    Device Name
    ACCURA ELITE SHUNT SYSTEM
    K Number
    K024040
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phoenix Biomedical Corp.
    Date Received
    December 6, 2002
    Decision Date
    January 27, 2003
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Phoenix Biomedical Corp.

    K Number Device Name
    K030468 ACURA ELITE GRAVITY COMPENSATING RESERVOIR
    K024101 PHOENIX UNIVERSAL SHUNT SYSTEM
    K021644 PERF (OMMAYA STYLE) RESERVOIRS
    K002476 LUMBOPERITONEAL SHUNT SYSTEM
    K000514 RUMBAR DRAINAGE SYSTEM
    K991429 DIAMOND II VALVE
    K990256 CRX WORLD SHUNT
    K974096 CRX DIAMOND VALVE
    K962144 PHOENIX ETE TISSUE EXTENSION SYSTEM
    K960435 PHOENIX CRX VALVE
    Search all 12 clearances from Phoenix Biomedical Corp. →