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510(k) Data Aggregation

    K Number
    K011183
    Device Name
    OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Date Cleared
    2001-06-15

    (58 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL CONCEPTS (ASC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010711
    Device Name
    ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Date Cleared
    2001-05-22

    (74 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL CONCEPTS (ASC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002013
    Device Name
    OMNIPORT
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Date Cleared
    2000-09-29

    (88 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL CONCEPTS (ASC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993544
    Device Name
    SPACE-OR RETRACTOR
    Manufacturer
    ADVANCED SURGICAL CONCEPTS (ASC)
    Date Cleared
    1999-12-22

    (64 days)

    Product Code
    FFO
    Regulation Number
    876.4730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL CONCEPTS (ASC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.
    Device Description
    The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure. In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released. The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.
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