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510(k) Data Aggregation

    K Number
    K965034
    Device Name
    SORBASTACE
    Manufacturer
    HEMOSTACE LLC.
    Date Cleared
    1998-04-09

    (478 days)

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

    HEMOSTACE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
    Device Description
    The device consists of fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product. The granular product is packaged in single-patient use packets for convenient sprinkling into fresh traumatic, superficial lacerations or wounds. The device in intended to be applied to fresh, traumatic, superficial lacerations or wounds to absorb body fluid and stop minor bleeding. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. The polymeric granules absorb fluid into their interior spaces and adsorb fluid onto their surfaces, in volume approximately equal to the volume of the granules. The relatively large surface area of the granules fosters coagulation. Within the interior space of the granules, the astringent is dissolved by the fluid. The astringent released from the granules then acts within the wound site to have a local and limited protein coagulant effect to help arrest secretion and stop minor bleeding.
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