Icecure Medical - FDA 510(k) Cleared Devices

Icecure Medical, specializes in minimally invasive cryoablation systems for tumor treatment. The company develops advanced medical devices focused on General & Plastic Surgery applications, with a manufacturing facility in Caesarea, IL. Their ProSense® Cryoablation System enables needle-based tumor destruction using extreme cold, targeting breast cancer, kidney cancer, lung cancer, and other oncologic conditions.

Icecure Medical has submitted 1 FDA 510(k) submission and received 0 FDA 510(k) clearance in 2025. The company's regulatory activity is historical; no clearances have been granted in more than five years prior to 2025. The cleared indication covers local treatment of low-risk breast cancer in patients aged 70 and older using endocrine therapy.

Clinical evidence supporting the ProSense system includes the ICE3 trial, which demonstrated a 3.1% local recurrence rate and high patient and physician satisfaction with cosmetic outcomes. The company emphasizes cryoablation as a focused technology platform, avoiding competing ablation methods. Regulatory approvals vary by region worldwide.

Explore the company's FDA 510(k) submission history, cleared device names, product codes, and clearance dates in the database.