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510(k) Data Aggregation

    K Number
    K230015
    Device Name
    OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
    Date Cleared
    2023-06-16

    (164 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laurane Medical SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Omnibone™ Bone Marrow Biopsy Kit is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients. The Omnibone™ Bone Biopsy Kit is indicated for bone biopsy of the vertebral body and bone lesions.
    Device Description
    The OmniBone™ Powered Biopsy System consists of a rechargeable Power Driver with Charger and compatible Biopsy Kits with Power Driver Pouch. The OmniBone™ Bone Biopsy Kit with Power Driver Pouch and the OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch are both provided sterile (EtO), are both single-use and are both designed exclusively for use with the OmniBone™ Power Driver. All OmniBone™ Biopsy Kits are available in different needle gauge sizes and lengths. The OmniBone™ Power Driver with Charger is a handheld, Lith-on battery powered, and rechargeable Power Driver, reusable and supplied non-sterile. The OmniBone™ Power Driver has a 3-position switch that controls the motion of the driver: reverse (counter clockwise) – off – forward (clockwise). The OmniBone™ Power Driver has a variable speed trigger that controls the speed of the driver. Applying light pressure on the trigger activates the driver at low speed and increasing the trigger pressure activates higher speeds. Full pressure on the trigger will activate full speed. No pressure on the trigger will stop the motor function. A charging LED indicates the level of charge of the battery of the OmniBone™ Power Driver. An integrated connector allows the OmniBone™ Power Driver to connect to the OmniBone™ Charger.
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