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510(k) Data Aggregation

    K Number
    K091061
    Device Name
    IMPLICITGUIDE SURGICAL SUTURE SYSTEM
    Manufacturer
    IMPLICITCARE, LLC
    Date Cleared
    2009-11-13

    (213 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLICITCARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implicitguide™ Surgical Suture System is indicated for use in soft tissue approximation and elevation of subdermis and underlying muscle.
    Device Description
    The ImplicitCare Implicitguide™ Surgical Suture System combines USP size 4-0 braided nonabsorbable poly(ethylene terephthalate), or polyester, surgical suture with a set of manual instruments designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components of the Implicitguide™ Surgical Suture System are provided sterile, and are intended for single use only. The manual instruments consist of the following: Tape (marking tape) to aid in marking the skin for needle (Suturod) point of entry locations)- if needed, Lancet to create a point of entry for needle (Suturod) and suture, Clearing device to clear subcutaneous ligamentous attachments around the puncture site, Two (2) stainless steel Suturods™ which, like suture needles, guide the suture through the tissue. Each Suturod™ has an internal light guide which, when connected to the Light Handle, illuminates the distal tip of the Suturod™M, Light Handle which contains an LED light source to connect to Suturod™.
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