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    K Number
    K033359
    Device Name
    DEGALL II GALLBLADDER EXTRACTOR
    Manufacturer
    SURGICON, INC.
    Date Cleared
    2003-12-19

    (59 days)

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

    SURGICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.
    Device Description
    The device consists of a polyurethane specimen container used in conjunction with a stainless steel cone retractor. The excised gallbladder, or other similar tissue specimen, is placed within the specimen bag. The bag is then brought within the confines of the cone retractor. The cone retractor is then used to shield the specimen during trans-abdominal extraction. The device can operate through a variety of trocar port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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    K Number
    K021747
    Device Name
    DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
    Manufacturer
    SURGICON, INC.
    Date Cleared
    2002-08-15

    (79 days)

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

    SURGICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.
    Device Description
    The device consists of an introducer and a polyurethane specimen container into which the excised gallbladder is placed. The device, with the specimen held within, is then withdrawn through the abdominal access wound (previously created by the trocar). The device can operate through a variety of access port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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