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510(k) Data Aggregation

    K Number
    K060465
    Device Name
    PREMIO
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2007-01-17

    (329 days)

    Product Code
    MXW
    Regulation Number
    878.5010
    Why did this record match?
    Product Code :

    MXW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
    Device Description
    PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
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    K Number
    K052953
    Device Name
    NUVANCE* FACIAL REJUVENATION SYSTEM
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2006-03-06

    (137 days)

    Product Code
    MXW
    Regulation Number
    878.5010
    Why did this record match?
    Product Code :

    MXW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
    Device Description
    NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility. The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.
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