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510(k) Data Aggregation

    K Number
    K092726
    Device Name
    MESH GPS - LARGE, SMALL, SM, SM SMALL
    Manufacturer
    SURGICAL STRUCTURES LTD.
    Date Cleared
    2010-03-15

    (193 days)

    Product Code
    OQL, GCJ
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OQL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mesh GPS device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.
    Device Description
    The Mesh GPS facilitates the delivery of soft tissue prosthetics during the laparoscopic ventral hernia repair, by assisting surgeons with maneuvering, spreading and deploying hernia repair meshes in the abdominal cavity, resulting in easier final fixation to the abdominal wall and shortening of OR time. The device is comprised of three main components: an inflatable spreading balloon; an adaptor and an inflation unit/pump. The device's three components are sterile, single use and packed within a double pouch. The Spreading Inflatable Balloon is composed of biocompatible Thermoplastic Polyurethane (TPU). The balloon is the main component of the device which supports and facilitates the navigation and deployment of a mesh within the abdominal cavity. It is reversibly attached to the mesh using the mesh connectors, before its insertion into the body, then rolled together. Once located in the abdominal cavity it is easily spread at the desired location by inflating it using the external Inflation Pump. The balloon comes in several sizes/configurations to enable its use with a wide variety of meshes available on the market. The Inflation Tube is composed of biocompatible Thermoplastic Polyurethane (TPU). Its purpose is to transport the air from the external Inflation Pump into the Spreading balloon and inflate it and to externally grab the balloon by the suture passer and position it at the proper location within the abdominal cavity.
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