FDA OKs New Models of Pentax Medical’s i20c Video Endoscopes

Pentax Medical, a division of Hoya Group, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for new models of its i20c video endoscope series. The new models include the video colonoscope EC34-i20cL, upper GI scope EG27‑i20c, and right/left wheel extender OE-B17.

Working together with the company’s Inspira video processor EPK-i8020c, the i20c video endoscope series aims to support clinicians in detection, diagnosis, and therapy. Pentax Medical said benefits can be gained from endoscope ergonomics, advanced imaging, and enhanced maneuverability.

The new, slim models feature adjustable stiffness, ErgoFeel control body, and EasyOn connector. Pentax Medical said the design improvements can improve the quality of procedures and optimize the clinical workflow.

The newly cleared add-on right/left wheel extender is a reusable piece attached to the endoscope’s outer right/left wheel, which aims to improve the outer wheel’s accessibility for endoscopists with smaller hands.

“We are thrilled to deliver the slim additions to our well-received i20c endoscope series,” said Pentax Medical Americas president David Harrison. “We know that U.S. 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, maneuverability, and imaging to all endoscopists without exception.”

In August, Pentax and Advanced Sterilization Products earned FDA clearance of the DEC duodenoscope (ED34-i10T2s) compatibility with the STERRAD 100NX Sterilizer’a Ultra GI cycle. The DEC duodenoscope (ED34-i10T2s) is the first GI endoscope compatible with hydrogen peroxide gas plasma sterilization.