Olympus Receives FDA Clearance of RenaFlex™ Single-use Flexible Ureteroscope

Olympus has received the US FDA 510(k) clearance of its first single-use ureteroscope system, RenaFlex™, which is used to access and visualize the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones.

The RenaFlex system is designed to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. The RenaFlex ureteroscope can be used with endotherapeutic accessories to perform diagnostic and therapeutic procedures within the urinary tract.

Regardless of stone size, composition or location, Olympus offers a broad range of stone management solutions to confidently approach every patient or procedure, at any site of care. With the addition of the RenaFlex system, the stone management solution portfolio offers physicians options to be ready for every stone.

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, Vice President, Business Unit Leader for Urology/Gynecology at Olympus Americas.

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