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Olympus Announces FDA Clearance of RenaFlex

Company’s first single-use flexible ureteroscope for diagnostic and therapeutic procedures

Quality Digest
Wed, 05/08/2024 - 23:58
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(Olympus: Center Valley, PA) -- Olympus, a global medical technology company, has announced U.S. Food and Drug Administration 510(k) clearance of its first single-use ureteroscope system, RenaFlex, with full market availability to be announced at a later date.

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The RenaFlex single-use flexible ureteroscope system is used to access and visualize the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones. The RenaFlex system can 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.

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