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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 / October 2025 / K253226

510(k) cleared

UV5000W Handle

Uroviu Corporation · Oct 23, 2025 · K253226

FDA cleared the UV5000W Handle from Uroviu Corporation on Oct 23, 2025 under K253226, a special 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 Sep 29, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

Uroviu Corporation has one other decision in the tracker over the last 12 months: K250797 (UV5000 Handle).

Questions & Answers

What did FDA clear under K253226?

K253226 is the FDA 510(k) for UV5000W Handle, submitted by Uroviu Corporation. FDA's decision date was Oct 23, 2025, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the UV5000W Handle?

Uroviu Corporation, based in Los Altos, CA, is the applicant of record for K253226.

How long did the K253226 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 23, 2025, 24 days later.

← All decisions in October 2025

Sources