Pentax Medical, a division of Japan’s Hoya Group, has received the US Food and Drug Administration (FDA) 510(k) approval for new models of its i20c family of video endoscopes.
The new models include Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17.
The FDA approval follows the CE mark approval for the same models in February this year.
Pentax Medical said the new i20c endoscope models, when used together with its INSPIRA Video Processor EPK-i8020c, support the detection, diagnosis, and treatment.
Also, the devices allow healthcare professionals to instantly benefit from superior ergonomics, advanced imaging, and enhanced manoeuvrability, said the company.
Pentax Medical Americas president David Harrison said: “We are thrilled to deliver the slim additions to our well-received i20c endoscope series.
“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.
“With the new EC34-i20cL and EG27-i20c, this complete portfolio is poised to deliver better ergonomics, manoeuvrability, and imaging to all endoscopists without exception.”
According to the company, the new models retain the features of the i20c endoscopes, including advanced imaging and enhanced manoeuvrability with adjustable stiffness.
Also, the models feature superior ergonomics through the new ErgoFeel control body and EasyOn connector to improve the experiences of medical professionals.
Pentax said the design improvements would improve the quality of procedures and optimise the clinical workflow.
In addition to the two new endoscope models, the company received FDA approval for its add-on Right/Left Wheel Extender, model OE-B17.
The extender is a reusable part attached to the outer right/left wheel of the endoscope to improve the access of the outer wheel by endoscopists with smaller hands.
