LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250319

    Validate with FDA (Live)

    Device Name
    MFUSE (MS001)
    Manufacturer
    Machina Medical, Inc.
    Date Cleared
    2025-12-15

    (314 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K061079,K240713
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MFUSE™ is indicated for temporary external use for controlling moderate to severe bleeding.

    Device Description

    MFUSE™ is a sterile, single-use, disposable device designed to stop bleeding by creating an barrier over the wound. The device will be used by healthcare professionals to temporarily stop moderate to severe bleeding. The device is comprised of polyacrylic acid (PAA) in a chitosan matrix. The PAA / chitosan structure is mixed with mineral oil to form a paste that is cream to light yellow in color. MFUSE™ is provided in a 5gm (mL) quantity syringe. The syringe is packaged in a foil pouch and is terminally sterilized with gamma sterilization.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1