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510(k) Data Aggregation

    K Number
    K253923

    Validate with FDA (Live)

    Device Name
    PuraStat
    Manufacturer
    3-D Matrix Europe SAS
    Date Cleared
    2026-01-07

    (30 days)

    Product Code
    PHN
    Regulation Number
    N/A
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K242634
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K242634

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 also commercially available.

    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.

    AI/ML Overview

    N/A

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