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510(k) Data Aggregation

    K Number
    K193018
    Device Name
    Surgical Direct Hand-held Laparoscopic Instruments
    Date Cleared
    2019-12-20

    (52 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Direct, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.
    Device Description
    The SURGICAL DIRECT Hand-held Laparoscopic Instruments are commonly named hand-held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.
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