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510(k) Data Aggregation

    K Number
    K251757

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-05

    (210 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation for mechanical cleansing and removal of debris from wounds, including microorganisms.

    Device Description

    Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of microorganisms within the solution. The mechanical action of the solution moving across the wound, combined with the hydrodynamic shear provided by mechanical irrigation, aids in the removal of debris and contaminants such as dirt, debris, and microorganisms.

    Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.

    AI/ML Overview

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