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510(k) Data Aggregation

    K Number
    K071732
    Device Name
    MARROWMINER
    Manufacturer
    STEMCOR SYSTEMS, INC.
    Date Cleared
    2007-09-24

    (90 days)

    Product Code
    GDM, GAA
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GDM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MarrowMiner is intended for harvesting bone marrow.
    Device Description
    The MarrowMiner is a device intended for harvesting bone marrow. The StemCor MarrowMiner bone marrow collection system is comprised of four components; a MarrowMiner battery powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide. The tip of the flexible aspiration shaft rotates and aspirates bone marrow. The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity.
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    K Number
    K971114
    Device Name
    BIOACCESS MARROW HARVEST SYSTEM
    Manufacturer
    BIOACCESS, INC.
    Date Cleared
    1997-06-03

    (69 days)

    Product Code
    GDM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GDM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
    Device Description
    The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.
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