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

Benefits of the system, according to a news release, include maneuverability and visualization.

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.

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