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510(k) Data Aggregation

    K Number
    K190677
    Device Name
    EndoClot
    Manufacturer
    EndoClot Plus Co., Ltd.
    Date Cleared
    2021-01-29

    (686 days)

    Product Code
    QAU
    Regulation Number
    878.4456
    Why did this record match?
    Applicant Name (Manufacturer) :

    EndoClot Plus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.
    Device Description
    EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). The device contains no human or animal components. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch.
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    K Number
    K191254
    Device Name
    EndoClot
    Manufacturer
    EndoClot Plus Co., Ltd.
    Date Cleared
    2020-01-30

    (265 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    EndoClot Plus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
    Device Description
    EndoClot® Submucosal Injection Agent is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are dissolved with sterile 0.9% saline to make the agent prior to use. The syringe has a Luer lock fitting to ensure a secure connection to a standard, commercially available endoscopic injection needle. The agent can be injected by rotating the plunger.
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    K Number
    K162197
    Device Name
    EndoClot
    Manufacturer
    EndoClot Plus Co., Ltd.
    Date Cleared
    2017-01-18

    (166 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    EndoClot Plus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.
    Device Description
    EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.
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