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510(k) Data Aggregation

    K Number
    K230646
    Device Name
    SUREcore Prime Biopsy Instrument
    Date Cleared
    2023-11-29

    (266 days)

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

    Uro-1 Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UR0-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.
    Device Description
    The SUREcore Prime Biopsy Instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Prime device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can reenergize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue.
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