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510(k) Data Aggregation

    K Number
    K253140

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-10

    (138 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CollOvine™ Wound Powder is indicated for the management of wounds including:

    • full-thickness & partial-thickness wounds
    • pressure ulcers
    • venous ulcers
    • diabetic ulcers
    • partial thickness burns
    • donor sites and other surface wounds
    • abrasions
    • traumatic wounds healing by secondary intention
    • acute wounds
    Device Description

    CollOvine™ Wound Powder 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 Powder is intended to maintain the moist wound environment.

    CollOvine™ Wound Powder is a primary wound dressing that can be sprinkled over the wound bed without the need to precut.

    CollOvine™ Wound Powder 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 Powder is a primary dressing, to maintain the moist wound bed environment.

    CollOvine™ Wound Powder is soft, pliable and free flowing.

    The ovine collagen for CollOvine™ Wound Powder is obtained from animal tissue, with sourcing, collection, storage and viral inactivation carried out in compliance with ISO22442.

    AI/ML Overview

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