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510(k) Data Aggregation

    K Number
    K121370
    Device Name
    VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
    Manufacturer
    VECTEC
    Date Cleared
    2013-08-02

    (452 days)

    Product Code
    FHO, FHP, HIF
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VECTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
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    K Number
    K103707
    Device Name
    VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
    Manufacturer
    VECTEC
    Date Cleared
    2011-02-04

    (46 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    VECTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTEC Disposable Monopolar Connection Cable is a sterile single-use device used to connect high frequency monopolar electrosurgical generators to various models of electrosurgical surgical instruments during laparoscopic and endoscopic surgery.
    Device Description
    The VECTEC Disposable Monopolar Cable is a 2.5 m cable used during routine laparoscopy and endoscopy procedures as the means of conveying high frequency electrical energy from a standard electrosurgical generator to standard electrosurgical instruments during surgery. Examples of such instruments include the range of VECTEC monopolar Scissors, Forceps, Dissectors, and Hook. VECTEC Disposable Monopolar Cables are single-use, sterile devices that are packaged individually and have a 2 or 5-year shelf life providing that the packaging is not damaged. The VECTEC monopolar cable is convenient for use in the operating room while having the high degree of performance expected from a surgical monopolar cable.
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    K Number
    K071976
    Device Name
    VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
    Manufacturer
    VECTEC
    Date Cleared
    2007-09-06

    (51 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    VECTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
    Device Description
    The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.
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