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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K250797

510(k) cleared

UV5000 Handle

Uroviu Corporation · Sep 11, 2025 · K250797

FDA cleared the UV5000 Handle from Uroviu Corporation on Sep 11, 2025 under K250797, a traditional 510(k). The device falls under product code FAJ, Cystoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 14, 2025. The decision came 181 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Uroviu Corporation has one other decision in the tracker over the last 12 months: K253226 (UV5000W Handle).

Questions & Answers

What did FDA clear under K250797?

K250797 is the FDA 510(k) for UV5000 Handle, submitted by Uroviu Corporation. FDA's decision date was Sep 11, 2025, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the UV5000 Handle?

Uroviu Corporation, based in Los Altos, CA, is the applicant of record for K250797.

How long did the K250797 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Sep 11, 2025, 181 days later.

← All decisions in September 2025

Sources