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510(k) Data Aggregation

    K Number
    K030174
    Device Name
    GENICON LAPAROSCOPES
    Manufacturer
    GENICON, LC
    Date Cleared
    2003-06-19

    (153 days)

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

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.
    Device Description
    The GeniCon Platinum Series Laparoscope is a reusable device with a glass rod lens assembly that connects an eyepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel shaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.
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    K Number
    K030269
    Device Name
    GENICON CLIP APPLIER
    Manufacturer
    GENICON, LC
    Date Cleared
    2003-03-20

    (52 days)

    Product Code
    FZP, GDO
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
    Device Description
    The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
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    K Number
    K002542
    Device Name
    REUSABLE CANNULA
    Manufacturer
    GENICON, LC
    Date Cleared
    2000-10-23

    (68 days)

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

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993625
    Device Name
    INSUFFLATION NEEDLE- 120MM, MODEL 900-200
    Manufacturer
    GENICON, LC
    Date Cleared
    2000-06-20

    (238 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon Pnutemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.
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    K Number
    K991382
    Device Name
    SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
    Manufacturer
    GENICON, LC
    Date Cleared
    1999-07-15

    (85 days)

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

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons. The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
    Device Description
    This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated. Trocar Tip: - A modified single slit tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula. Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion. Cannula: - Trapezoidal fascia threads, they provide an easier insertion while a positive anchoring during . instrument use. - CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer . cap is easier to remove and replace than the Apple silicone cap. - . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
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    K Number
    K982472
    Device Name
    GENICON TROCAR
    Manufacturer
    GENICON, LC
    Date Cleared
    1999-02-04

    (204 days)

    Product Code
    GEA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENICON, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
    Device Description
    This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated. Trocar Tip: - A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula. Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion. Cannula: - Clear casing for visualization of instrument and tissue passage. . - Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use. - . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap. - . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product. Valve: - . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use. - . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
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