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510(k) Data Aggregation

    K Number
    K251582

    Validate with FDA (Live)

    Date Cleared
    2026-02-02

    (255 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

    Redermax Antibacterial Wound Matrix is intended for the management of wounds. Redermax Antibacterial Wound Matrix is indicated for the management of:

    • Partial and full thickness wounds
    • Pressure ulcers
    • Venous ulcers
    • Diabetic ulcers
    • Chronic vascular ulcers
    • Tunneled/undermined wounds
    • Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
    • Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
    • Draining wounds.
    Device Description

    Redermax Antibacterial Wound Matrix is a sterile, single-use device intended for use in the management of wounds. Redermax is a soft, white, conformable, non-friable, absorbable, three-dimensional matrix that provides an environment for the body's healing process to occur. Redermax is supplied dry in sheet form. The device consists of composite fibers made from biocompatible and biodegradable materials. With the defined rate of absorption, the matrix provides a structural structure for wound healing before complete degradation through hydrolysis. Redermax is a porous matrix composed of poly(lactic-glycolic acid) (PLGA), polydioxanone (PDO), Poloxamer 188, and poly (hexamethylene biguanide) hydrochloride (PHMB), and based on in vitro testing, the PHMB effectively reduces the growth of bacteria within the Redermax Wound Matrix for a period of up to 7 days. The device does not contain any human or animal materials or tissue.

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