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510(k) Data Aggregation

    K Number
    K230142
    Device Name
    Epi-Stop Nasal Gel/epistaxis pack
    Manufacturer
    BioMed ENT, Inc.
    Date Cleared
    2023-03-22

    (63 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioMed ENT, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to: - Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation; - Act as an adjunct to aid in the natural healing process. Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.
    Device Description
    Epi-Stop™ Nasal Gel/Epistaxis Pack is a single use, hemostatic, and injectable gel, made of crosslinked gelatin and hyaluronic acid, indicated for the treatment of anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack creates a moist environment for healing and the ability of absorbing and stopping nose bleeding within minutes. Due to its viscoelasticity and low extrusion force, Epi-Stop™ Nasal Gel/Epistaxis Pack can be injected into the anterior nasal cavity and the gel must be left in the nose for at least 72 hours. Afterwards, the gel can be removed by using safe water for gentle irrigation (either sterile or boiled water) or using safe lukewarm water.
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