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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 / July 2026 / K260161

510(k) cleared

SmartGuide Disposable Guides and Grids

UC-CARE , Ltd. · Jul 30, 2026 · K260161

FDA cleared the SmartGuide Disposable Guides and Grids from UC-CARE , Ltd. on Jul 30, 2026 under K260161, a traditional 510(k). The device falls under product code ITX, Transducer, Ultrasonic, Diagnostic, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 20, 2026. The decision came 191 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

UC-CARE , Ltd. has 2 other decisions in the tracker over the last 12 months: K253918 (Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)), K252704 (F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)).

Questions & Answers

What did FDA clear under K260161?

K260161 is the FDA 510(k) for SmartGuide Disposable Guides and Grids, submitted by UC-CARE , Ltd.. FDA's decision date was Jul 30, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the SmartGuide Disposable Guides and Grids?

UC-CARE , Ltd., based in Yokneam, is the applicant of record for K260161.

How long did the K260161 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Jul 30, 2026, 191 days later.

← All decisions in July 2026

Sources