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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 / February 2026 / K260377

510(k) cleared

XSense Cryoablation System with CryoProbes

IceCure Medical , Ltd. · Feb 24, 2026 · K260377

FDA cleared the XSense Cryoablation System with CryoProbes from IceCure Medical , Ltd. on Feb 24, 2026 under K260377, a special 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 5, 2026. The decision came 19 days later, inside the 90 FDA-day goal for a 510(k).

IceCure Medical , Ltd. has one other decision in the tracker over the last 12 months: DEN220077 (ProSense System).

Questions & Answers

What did FDA clear under K260377?

K260377 is the FDA 510(k) for XSense Cryoablation System with CryoProbes, submitted by IceCure Medical , Ltd.. FDA's decision date was Feb 24, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the XSense Cryoablation System with CryoProbes?

IceCure Medical , Ltd., based in Caesarea, is the applicant of record for K260377.

How long did the K260377 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Feb 24, 2026, 19 days later.

← All decisions in February 2026

Sources