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510(k) Data Aggregation

    K Number
    DEN110016
    Device Name
    PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
    Date Cleared
    2012-04-30

    (222 days)

    Product Code
    Regulation Number
    878.4805
    Why did this record match?
    Product Code :

    OXT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Percutaneous Surgical Set with 5 mm or 10 mm Attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue.
    Device Description
    The Percutaneous Surgical Set with 5mm or 10mm Attachments is a family of minimally invasive devices that can penetrate soft tissue, be assembled in situ, and allow access to certain areas of the abdomen. The Set is designed for assembly within the abdomen to grasp, hold or manipulate soft tissue. There attachments (or end effectors): a 5 mm grasper, 5 mm Maryland dissector and a 10 mm Babcock grasper. The attachments can be mounted individually to the 3 mm percutaneous metal shaft. The device is for single use only and is disposable.
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