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510(k) Data Aggregation

    K Number
    K964256
    Device Name
    CYGNUS INSTRUMENT PROTECTORS
    Date Cleared
    1997-05-06

    (193 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MADISON POLYMERIC ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary purpose of the device is to protect surgical instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.
    Device Description
    The "Cygnus Instrument Protectors" liners and pouches are constructed with reticulated polyurethane ester foam. The material's open cell structure allows for the free flow of air, moisture and heat and is virtually free of particulate matter. The variety of sizes and shapes allows for greater flexibility in padding the instruments. Tray liners are available in precut sheets and rolls. uthe pouches are available in three sizes of single pouches and two sizes of multi pouch rolls. The pouches are formed by heat sealing the edges and seams. Each product is available in individual boxes as well as bulk case packaging. The products are shipped and marked as "non sterile" and "disposable". Each box is marked with a control lot number and universal bar code.
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    K Number
    K965086
    Device Name
    CYGNUS ELECTROSURGICAL TIP CLEANER
    Date Cleared
    1997-02-14

    (57 days)

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

    MADISON POLYMERIC ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.
    Device Description
    The body of the device is constructed of a polyurethane ester foam. A grit sheet is laminated to the top surface of the foam, and a pressure sensitive adhesive and release liner laminated to the base of the pad. An X-Ray detectable rod is placed between the pressure sensitive adhesive and the foam. The device is available in three sizes. Each pad is individually wrapped and sterilized for use. Sterilization will be by Gamma Ray or ETO and will be conducted and certified by a contract sterilization firm.
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