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510(k) Data Aggregation

    K Number
    K260532

    Validate with FDA (Live)

    Device Name
    Derma-Gide
    Date Cleared
    2026-03-19

    (30 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

    Derma-Gide is intended for the management of wounds including:

    • partial and full thickness wounds
    • pressure ulcers
    • venous ulcers
    • diabetic ulcers
    • chronic vascular ulcers
    • surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
    • trauma skin wounds (abrasions, laceration, partial thickness second degree burns, skin tears)
    Device Description

    Derma-Gide is a sterile, single-use only, acellular advanced wound care device primarily derived from porcine collagen. Derma-Gide features a bilayer structure. The upper dense compact collagen layer protects the wound. This structure has a smooth texture with appropriate pull-out strength properties to allow suturing. The second lower layer consists of a thick, porous spongeous collagen scaffold.

    Derma-Gide is provided in rectangular and round shapes in multiple sizes/diameters.

    AI/ML Overview

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