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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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).

This is the only decision on file for IceCure Medical , Ltd. in the last 12 months of the tracker.

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