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510(k) Data Aggregation

    K Number
    K103269
    Device Name
    PATCHASSIST LARGE
    Manufacturer
    POLYTOUCH MEDICAL LTD
    Date Cleared
    2010-11-23

    (19 days)

    Product Code
    ORQ
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYTOUCH MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PatchAssist™ device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
    Device Description
    The PatchAssist™ device is used to facilitate the delivery of mesh during the laparoscopic hernia repair. It is a tray like device that holds the mesh under tension and enables the surgeon to connect the mesh to its proper place. The PatchAssist™ device are manual laparoscopic surgical instrument. The surgeon connects a standard hernia mesh (not part of the device) to the device using a dedicated stapling apparatus, furls the mesh on the device deployment section (as it is a dedicated stapling apparatus), and inserts the device into the abdominal cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the device enables the surgeon to rapidly maneuver the mesh into position over the hernia, over the desired surgical location. The mesh is attached and placing the mesh is connected to the tissue using the same technique as currently performed by the surgeon (e.g., suturing or using fixated tacks). Upon the mesh fixation to the tissue, the surgeon releases the mesh from the device and removes the device from the abdominal cavity leaving the fixated mesh in its desired location. The PatchAssist™ Large is another model of the PatchAssist™ that has a slightly larger deployment frame to facilitate the insertion of large size meshes.
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    K Number
    K101218
    Device Name
    PATCHASSIST
    Manufacturer
    POLYTOUCH MEDICAL LTD
    Date Cleared
    2010-06-17

    (48 days)

    Product Code
    ORQ, ORO
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYTOUCH MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PatchAssist device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
    Device Description
    The PatchAssist device is a single use device that will be provided sterile.
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