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510(k) Data Aggregation

    K Number
    K161939
    Device Name
    Avance Abdominal Dressing Kit
    Manufacturer
    Molnlycke Health Care US, LLC
    Date Cleared
    2016-11-17

    (126 days)

    Product Code
    OXJ, OMP
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.
    Device Description
    The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.
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    K Number
    K130852
    Device Name
    AVANCE® FOAM ABDOMINAL DRESSING KIT
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Date Cleared
    2014-04-14

    (382 days)

    Product Code
    OXJ, OMP
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.
    Device Description
    The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Abdominal Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds. The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The Avance® Foam Abdominal Dressing Kit consists of the following components: Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines. Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system. Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal. A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.
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