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FDA Grants 510(k) Clearance to Pentax Medical Inspira and Ergonomic i20c Endoscopes
The devices will be available commercially in October 2023.
Pentax Inspira
Pentax Medical America Inc. announced that the FDA has granted 510(k) clearance to two products: the Inspira video processor and the i20c video endoscope series. The two devices will be commercially available in October 2023.
The Inspira is a 4k video processor that connects with the Pentax endoscope portfolio. It is also able to perform image enhancement that has the ability to improve Adenoma Detection Rate.
The i20c endoscope is designed to fit comfortably into most hands and includes a dynamic insertion tube designed to increase mobility in challenging anatomies.
In a press release, Pentax president David Harrison said, “The Pentax Medical Inspira™ video processor and i20c Endoscopes are a milestone for endoscopy in the United States. This platform not only addresses current ergonomic needs but sets future standards in the endoscopy workflow that will ultimately strengthen the provider and patient experience. Together, the system empowers endoscopists with the economic flexibility, a 4K imaging option, and maneuverability tools they need to improve patient care."
