Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K981928
    Device Name
    GALILEO DISPOSABLE ENDOSCOPES
    Manufacturer
    GALILEO ELECTRO-OPTICS CORP.
    Date Cleared
    1998-08-06

    (65 days)

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

    GALILEO ELECTRO-OPTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Disposable Endoscopes are endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Disposable Endoscopes indications for use include choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
    Device Description
    The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology. The Galileo Disposable Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user.
    Ask a Question
    K Number
    K962256
    Device Name
    GALILEO HYSTEROSCOPES AND LAPAROSCOPES
    Manufacturer
    GALILEO ELECTRO-OPTICS CORP.
    Date Cleared
    1996-12-06

    (177 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALILEO ELECTRO-OPTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
    Device Description
    The Galileo Hysteroscopes and Laparoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Hysteroscopes and Laparoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
    Ask a Question
    K Number
    K962116
    Device Name
    GALILEO ENDOSCOPES
    Manufacturer
    GALILEO ELECTRO-OPTICS CORP.
    Date Cleared
    1996-11-27

    (180 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    GALILEO ELECTRO-OPTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.
    Device Description
    The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
    Ask a Question

    Page 1 of 1