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510(k) Data Aggregation

    K Number
    K213228
    Device Name
    NeuroLine Disposable Cranial Perforator with Hudson end
    Manufacturer
    EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft.
    Date Cleared
    2022-06-20

    (264 days)

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

    EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.
    Device Description
    The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone. The perforator has Hudson type connection and can connect to all the driver units with Hudson connection. Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters. Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.
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