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510(k) Data Aggregation

    K Number
    K252001

    Validate with FDA (Live)

    Date Cleared
    2025-10-10

    (105 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

    Indications for Use (Describe)

    Prescription Use

    Collagen Wound Dressing is indicated for the management of exuding wounds including:

    • Full thickness and partial thickness wounds
    • Pressure and venous ulcers
    • Ulcers caused by mixed vascular etiologies
    • Diabetic ulcers
    • Partial thickness burns
    • Donor sites and other bleeding surface wounds
    • Abrasions
    • Traumatic wound healing by secondary intention
    • Dehisced surgical incisions

    Over-The-Counter Use

    Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.

    Device Description

    Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.

    AI/ML Overview

    N/A

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