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510(k) Data Aggregation

    K Number
    K240097
    Device Name
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
    Manufacturer
    Ushare Medical Inc.
    Date Cleared
    2024-05-22

    (131 days)

    Product Code
    QSY, OSY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ushare Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
    Device Description
    The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.
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    K Number
    K191472
    Device Name
    Biopsy Needle
    Manufacturer
    Ushare Medical Inc.
    Date Cleared
    2020-01-29

    (240 days)

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

    Ushare Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone. The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
    Device Description
    The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
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