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510(k) Data Aggregation

    K Number
    K211318
    Device Name
    PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
    Manufacturer
    Smith Nephew Medical Limited
    Date Cleared
    2022-01-05

    (250 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Smith Nephew Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Venous Leg Ulcers - PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers - Flaps and grafts - Closed surgical incisions PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.
    Device Description
    The PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems consist of: • PICO Pump • Batteries • PICO Dressing (s) • Instructions for Use • Fixation Strips PICO Fluid Management Packs consist of 5 individually packaged PICO dressings designed for use with PICO devices. PICO 7 and PICO 14 are canister-free single use Negative Pressure Wound Therapy Systems and use an absorbent dressing connected to the PICO pump via a tubing and port. Wound exudate is managed by PICO dressing using a combination of absorption and evaporation. The PICO pump provides the additional benefit of -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy to the wound.
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