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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?
    Product Code :

    PHN

    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
    K213552
    Device Name
    PuraStat-RM
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2022-04-01

    (144 days)

    Product Code
    PHN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    PHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
    Device Description
    PuraStat-RM 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 syringe via the polypropylene adapter. PuraStat-RM is completely non-animal and non-plant derived and contains no drugs or biologics 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
    K140558
    Device Name
    PROCTIGARD
    Manufacturer
    ACCESS PHARMACEUTICALS, INC
    Date Cleared
    2014-07-16

    (133 days)

    Product Code
    PHN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    PHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProctiGard™ is indicated for the symptomatic management of rectal mucositis.
    Device Description
    ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.
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