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510(k) Data Aggregation

    K Number
    K230619
    Device Name
    Hubly Electric Drill (H100)
    Manufacturer
    Hubly Inc.
    Date Cleared
    2023-05-04

    (59 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hubly Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hubly Electric Drill is a single-use, sterile, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
    Device Description
    The Hubly Electric Drill is a battery powered cranial drill. It is single-use disposable and provided ethylene oxide sterilized. The drill is designed to create optimal burr holes, in the emergency room, at the bedside, or in the operating room. The system is designed to streamline bedside intracranial access and facilitate the treatment of emergent conditions in adult patients. The device is a battery-powered hand drill which can be used one-handed using either hand. The drill is trigger-activated after removal of the battery pull tab. The drill has a single speed and turns off when the trigger is released. The drill bit has depth indicators at 5 and 10mm depth, which the physician may use to visually gauge depth of penetration while drilling. The drill also has an auto-stop feature which detects when the bit breaks through the inner table of the skull and immediately stops the drill. The device has an LED indicator which indicates to the user (green) when they are applying enough force and (red) when the drill stops. The drill features mechanical plunge prevention with a tapered stainless steel drill may be reactivated any number of times using the trigger if the physician desires.
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