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510(k) Data Aggregation

    K Number
    K242985
    Device Name
    CollOvine™ Wound Dressing
    Manufacturer
    OviGenex LLC
    Date Cleared
    2025-06-20

    (267 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    OviGenex LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollOvine™ Wound Dressing is indicated for the management of exuding wounds including: - full-thickness & partial-thickness wounds - pressure ulcers - venous ulcers - ulcers caused by mixed vascular etiologies - diabetic ulcers - superficial second-degree burns - donor sites and other bleeding surface wounds - abrasions - traumatic wounds healing by secondary intention - dehisced surgical incisions
    Device Description
    CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed. CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4". CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed. CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate. CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable. The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.
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