Several ductoscope devices have been approved for use by the U.S. Food and Drug Administration (FDA). These 510(k) devices are now considered unclassified by the FDA. According to the FDA a ductoscope is a device intended for use in viewing an interior cavity of the human body through either a natural opening or an incision. Examples of these devices include the ViaDuctTM Microendoscope (Acueity Inc., Palo Alto, CA) which received 510(k) approval on July 16, 2001 and the MastascopeTM (Lifeline Biotechnologies, Pompano Beach, FL), approved in June 2004.
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