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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 / K251928

510(k) cleared

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Medinice S.A. · Feb 13, 2026 · K251928

FDA cleared the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) from Medinice S.A. on Feb 13, 2026 under K251928, a traditional 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 Jun 23, 2025. The decision came 235 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medinice S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251928?

K251928 is the FDA 510(k) for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21), submitted by Medinice S.A.. FDA's decision date was Feb 13, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

Medinice S.A., based in Warsaw, is the applicant of record for K251928.

How long did the K251928 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Feb 13, 2026, 235 days later.

← All decisions in February 2026