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510(k) Data Aggregation

    K Number
    DEN230032
    Device Name
    Symani Surgical System
    Date Cleared
    2024-04-05

    (346 days)

    Product Code
    Regulation Number
    878.4963
    Why did this record match?
    Applicant Name (Manufacturer) :

    MMI North America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
    Device Description
    The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments. The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital. Symani is composed of three main components (Figure 1): - The Console, which is a reusable equipment and not sterile; . - The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and - . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide
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