FDA grants 510(k) clearance to RenaFlex ureteroscope system

The FDA has granted 510(k) clearance to the RenaFlex single-use flexible ureteroscope system for use in the treatment of patients with urinary diseases such as kidney stones, announced Olympus, the developer of the system, in a news release.¹

The RenaFlex ureteroscope system includes 270-degree up and down angulation and a 9.5Fr outer diameter with a 3.6Fr working channel

"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, MBA, vice president and business unit leader for urology/gynecology at Olympus Corp. of the Americas, in the news release.¹ "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."

The RenaFlex ureteroscope system is intended for use in accessing and visualizing the urinary tract (the urethra, bladder, ureter, calyces, and renal papillae) via transurethral or percutaneous access routes. The ureteroscope is designed to work in combination with the compatible CV-S1 video system center for flexible single-use endoscopes.

According to Olympus, the RenaFlex system includes a lightweight, ergonomic ureteroscope handle, as well as a flexible shaft with stiff and passive bending sections. Additionally, the system provides high-quality visualization and is equipped with an advanced camera chip within the distal tip to allow for 120-degree visualization with auto white balancing and brightness.

Further, the RenaFlex system includes 270-degree up and down angulation and a 9.5Fr outer diameter with a 3.6Fr working channel. The system requires minimal OR space owing to its simple set-up.

Olympus submitted the application for US FDA clearance of the RenaFlex ureteroscope system in September 2023.² With this clearance, RenaFlex is the latest product on the line of stone management solutions at Olympus, adding to their portfolio of flexible and rigid ureteroscopes.³

The company plans to announce full market availability of the RenaFlex ureteroscope system at a later date.

References

1. Olympus announces FDA clearance of RenaFlex, its first single-use flexible ureteroscope. News release. Olympus Corporation of the Americas. Published online and accessed April 2, 2024. https://www.olympusamerica.com/press-release/2024-04-02/olympus-announces-fda-clearance-renaflextm-its-first-single-use-flexible

2. 510(k) premarket notification. US Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233275

3. Ureteroscopy. Olympus. https://medical.olympusamerica.com/procedure/ureteroscopy