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510(k) Data Aggregation

    K Number
    K242634
    Device Name
    PuraStat
    Manufacturer
    3-D Matrix Europe SAS
    Date Cleared
    2025-01-15

    (134 days)

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

    3-D Matrix Europe SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Purastat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
    Device Description
    PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1. 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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    K Number
    K242250
    Device Name
    PuraStat
    Manufacturer
    3-D Matrix Europe SAS
    Date Cleared
    2024-10-22

    (83 days)

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

    3-D Matrix Europe SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.
    Device Description
    PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1, 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.
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