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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 / K252594

510(k) cleared

UltraGuideCTR® image guided soft tissue release system

Sonex Health · Sep 29, 2025 · K252594

FDA cleared the UltraGuideCTR® image guided soft tissue release system from Sonex Health on Sep 29, 2025 under K252594, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 15, 2025. The decision came 45 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sonex Health in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252594?

K252594 is the FDA 510(k) for UltraGuideCTR® image guided soft tissue release system, submitted by Sonex Health. FDA's decision date was Sep 29, 2025, under product code HRX (Arthroscope).

Who makes the UltraGuideCTR® image guided soft tissue release system?

Sonex Health, based in Eagan, MN, is the applicant of record for K252594.

How long did the K252594 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Sep 29, 2025, 45 days later.

← All decisions in September 2025