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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 / June 2026 / K261342

510(k) cleared

Urocross Expander System (UES-2018-C1)

Prodeon Medical, Inc. · Jun 22, 2026 · K261342

FDA cleared the Urocross Expander System (UES-2018-C1) from Prodeon Medical, Inc. on Jun 22, 2026 under K261342, a traditional 510(k). The device falls under product code QKA, Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia, regulated at 21 CFR 876.5510 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 23, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Prodeon Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K253525 (Urocross Expander System (Model Numbers ES2018 and ES3025)), K252572 (Prodeon Urethral Sheath System).

Questions & Answers

What did FDA clear under K261342?

K261342 is the FDA 510(k) for Urocross Expander System (UES-2018-C1), submitted by Prodeon Medical, Inc.. FDA's decision date was Jun 22, 2026, under product code QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia).

Who makes the Urocross Expander System (UES-2018-C1)?

Prodeon Medical, Inc., based in San Jose, CA, is the applicant of record for K261342.

How long did the K261342 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Jun 22, 2026, 60 days later.

← All decisions in June 2026

Sources