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510(k) Data Aggregation

    K Number
    K141455
    Device Name
    EASYDRILL AUTOSTOP CRANIAL PERFORATOR
    Manufacturer
    MICROMAR IND. COM. LTD.
    Date Cleared
    2015-03-16

    (287 days)

    Product Code
    HBF
    Regulation Number
    882.4305
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROMAR IND. COM. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.
    Device Description
    The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors. The EasyDrill Autostop Cranial Perforator device is a bone cutting and drilling instrument used in conjunction with a surgical motor and a Hudson Chuck - speed reducer attachment, to drill access holes through a patient's skull. When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone. The EasyDrill Autostop Cranial Perforator is a mechanically powered tool, designed to create an access hole through the skull. The subject Perforator device derives its mechanical torque and rotational speed from various legally marketed Electric and/or Pneumatic Drill Motors. The EasyDrill Autostop Cranial Perforator device is latched onto a Hudson Chuck device, which is in turn attached to the Drill Motors. The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.
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