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Pentax wins FDA nod for new models of endoscopes

December 10, 2024 By Sean Whooley

Pentax Medical i20c video endoscope series (1)
The i20c video endoscope series. [Image courtesy of Pentax Medical]
Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series.

The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare professionals in detection, diagnosis and therapy. Physicians using the scopes can benefit from advanced ergonomics and imaging, plus enhanced maneuverability.

Pentax said its new slim models include the signature features of its previous generations of i20c endoscopes. They have adjustable stiffness and superior ergonomics through the new ErgoFeel control body and EasyOn connector. These features improve the experience for medical professionals, the company says. They could improve procedure quality while optimizing the clinical workflow.

In addition to the new endoscope models, Pentax Medical won clearance for its add-on Right-Left Wheel Extender, model OE-B17. The reusable piece improves the accessibility of the outer wheel for endoscopists with smaller hands.

“We know that US physicians have appreciated the ergonomic control body design changes we have made in the i20c series, and they have been anxiously awaiting these advancements in their slim scopes as well,” said David Harrison, president, Pentax Medical Americas. “With the new EC34-i20cL and EG27-i20c, this complete portfolio is poised to deliver better ergonomics, maneuverability, and imaging to all endoscopists without exception.”

Filed Under: 510(k), Endoscopes, Regulatory, Technologies & Devices Tagged With: pentax, Pentax Medical

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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