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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.

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.

This 510(k) summary does not contain information related to acceptance criteria or a study proving device performance. The document describes the device, its intended use, and compares it to legally marketed predicate devices, focusing on technological equivalence rather than performance validation against specific criteria.

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