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510(k) Data Aggregation

    K Number
    K234131
    Device Name
    Resolv Endoscopic Hemostat System
    Manufacturer
    Hemostasis LLC
    Date Cleared
    2024-07-26

    (211 days)

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

    Hemostasis LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220326
    Device Name
    PosiSep X BAM Hemostat Dressing/Intranasal Splint
    Manufacturer
    Hemostasis LLC
    Date Cleared
    2022-11-14

    (283 days)

    Product Code
    EMX, LYA
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hemostasis LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma; - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; - Help control minimal bleeding following surgery or trauma; - Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and - Act as an adjunct to aid in the natural healing process PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.
    Device Description
    The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy. PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents. PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.
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    K Number
    K210411
    Device Name
    PosiSep EAR Fragmentable Ear Dressing
    Manufacturer
    Hemostasis LLC
    Date Cleared
    2022-05-05

    (448 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hemostasis LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery: As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation. PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
    Device Description
    The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.
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