UroViu Receives FDA 510(k) Clearance for Its UV5000 Advanced Endoscope Platform

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LOS ALTOS, Calif.--(BUSINESS WIRE)--Sep 30, 2025--

UroViu Corporation is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its UV5000 cordless, single-use endoscope platform.

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The UV5000 replaces the current UV4500 on the market, offering a faster processor, longer battery life, and brighter HD visualization directly within the clinician's line of sight. It is compatible with all of UroViu's single-use endoscope cannulas, graspers, and biopsy forceps. As a companion to the UV5000, UroViu has submitted a 510(k) application for a model, the UV5000W, that has built-in Wi-Fi connectivity to external displays.

Bruce OuYang, Ph.D., CEO, commented, "UroViu strives to achieve a win-win situation for patients and care providers and has gained adoption across all segments of the market, including private practices, ASCs, academic institutions, VA, and DOD healthcare facilities, benefiting from the following unique features:

• Cordless, untethered design: This minimizes the environmental impact and carbon footprint of disposable products by eliminating any cords. The profile and weight of all our disposables are half or a third compared to similar products on the market.
• Portability and Simplicity: The UV5000 turns any room into a procedure room. This allows for schedule expansion, creating efficiency benefiting both the practice and patients.
• Versatile platform: The UV5000 platform allows for fast additions of new single-use cannulas optimized for various indications, aiming to provide a complete set of tools for users without investing in additional reusable devices."

The UV5000 is now available in the U.S. market. For more information or to schedule a hands-on demonstration, please contact UroViu's sales representatives or customer service as listed on https://www.uroviu.com.

UroViu Corp., based in Los Altos, California, develops, manufactures, and commercializes advanced single-use endoscopic visualization solutions worldwide. The company pioneered the world's most portable cystoscopy platform that is always ready, eliminating the need for reprocessing, capital equipment, servicing, and advance scheduling. UroViu's mission is to simplify workflows and expand access to high-quality endoscopy by integrating cutting-edge technologies, including edge AI and robotics.

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CONTACT: Media contact:

Bruce OuYang, Ph.D.

Chairman and CEO

Email:[email protected]

Mobile: 650-283-2778

Office: 650-878-6686

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: MEDICAL DEVICES FDA HOSPITALS HEALTH TECHNOLOGY PRACTICE MANAGEMENT BIOTECHNOLOGY OTHER HEALTH HEALTH GENERAL HEALTH

SOURCE: UroViu Corporation

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PUB: 09/30/2025 09:00 AM/DISC: 09/30/2025 09:02 AM

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