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510(k) Data Aggregation

    K Number
    K993851
    Device Name
    SODEM PERFORATOR DRIVE
    Manufacturer
    SODEMSYSTEMS
    Date Cleared
    1999-12-27

    (45 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    SODEMSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patien's skull. The system is intended for use in neurosurgery.
    Device Description
    The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System. the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter. Sodem is not manufacturing "Cranial Perforator attachment". The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System. The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor). This safety device is functional so far the speed range is being respected. The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation.
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