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510(k) Data Aggregation

    K Number
    K081782
    Device Name
    COLLIEVA
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2008-09-30

    (99 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K061746
    Why did this record match?
    Device Name :

    COLLIEVA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Collieva™ may be used for the management of wounds such as:

    • · Pressure ulcers
    • Venous stasis ulcers
    • · Diabetic ulcers
    • · First and second degree burns
    • · Partial and full thickness wounds
    • · Superficial injuries
    Device Description

    Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

    AI/ML Overview

    The provided text is a 510(k) summary for the device Collieva™, a topical wound dressing. It declares substantial equivalence to a predicate device (CollaGuard™) and includes information on intended use and biocompatibility. However, it does not contain any information about a study with acceptance criteria or reported device performance data.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document focuses on regulatory submission for substantial equivalence rather than performance testing against specific criteria.

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