Pentax Receives FDA Clearance for Latest Endoscope Series

Pentax Medical has announced that it has secured FDA 510(k) approval for the latest models within its i20c video endoscope lineup. The recent introductions – the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c, and the Right/Left Wheel Extender OE-B17 – are designed to integrate seamlessly with the Pentax Medical Inspira Video Processor EPK-i8020c. These tools support healthcare providers in tasks ranging from detection to diagnosis and therapy. Physicians will find the scopes offer superior ergonomics and imaging capabilities, along with enhanced maneuverability.

According to Pentax, the new, slimmer models retain the hallmark features of prior i20c endoscope versions. They boast adjustable stiffness and top-tier ergonomics, thanks to the updated ErgoFeel control body and EasyOn connector, features that are set to elevate the medical professionals’ experience. Such innovations promise to improve procedure quality while streamlining clinical workflows.

Alongside these advanced endoscopes, Pentax Medical also achieved clearance for its accessory, the Right-Left Wheel Extender, model OE-B17. This reusable component enhances the accessibility of the outer wheel, catering to endoscopists with smaller hands.

“We recognize the appreciation that US physicians have expressed for the ergonomic improvements in our i20c series, and their eagerness for these enhancements in our slim scope models,” remarked David Harrison, President of Pentax Medical Americas. “With the introduction of the EC34-i20cL and EG27-i20c, our complete range is set to provide unparalleled ergonomics, maneuverability, and imaging to every endoscopist.”