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Home » Olympus wins FDA clearance for its first single-use flexible ureteroscope

Olympus wins FDA clearance for its first single-use flexible ureteroscope

April 2, 2024 By Sean Whooley

Olympus RenaFlex single use ureteroscope
The RenaFlex single-use ureteroscope in use. [Image courtesy of Olympus]
Olympus announced today that the FDA granted 510(k) clearance for its RenaFlex single-use ureteroscope system.

The company expects to begin a full-market rollout at a later date.

RenaFlex offers access and visualization in the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones. It helps visualize organs, cavities and canals in the urinary tract via transurethral or percutaneous access routes. Olympus designed RenaFlex for use with endotherapeutic accessories for both diagnostic and therapeutic procedures.

Benefits of the system, according to a news release, include maneuverability and visualization. Its lightweight, ergonomic uteroscope handle and flexible shaft with stiff and passing bending sections enhance that maneuverability. Olympus designed it for high-quality, consistent visualization with an advanced camera chip within the RenaFlex’s distal chip. It enables a 120-degree field of view with auto white balancing and brightness.

Additionally, Olympus touts the system’s therapeutic active articulation (270-degree up/down angulation) and 9.5Fr outer diameter and 3.6Fr working channel. The system’s simple setup requires minimal operating room space as well.

“Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, including reusable and single-use flexible scopes to rigid and semi-rigid scopes, powerful lithotripsy solutions and simplified stone removal devices,” said Glen Branconier, VP, business unit leader for Urology/Gynecology at Olympus Corp. of the Americas. “We are excited and privileged to provide urologists and Health Care Providers with the tools they need to confidently care for their patients at any site of care.”

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, Urology Tagged With: FDA, Olympus

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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 [email protected].

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