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510(k) Data Aggregation

    K Number
    K172344
    Device Name
    Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
    Date Cleared
    2017-11-13

    (103 days)

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

    MEDAX S.R.L. UNIPERSONALE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDONE Soft tissue automatic disposable biopsy system: MEDONE biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy. MEDCUT automatic disposable biopsy system : MEDCUT biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy. MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest. MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy. MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.
    Device Description
    Medax Biopsy Systems II portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue or bone (depending on product family) for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length.
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