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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 / October 2025 / DEN220077

510(k) cleared

ProSense System

Icecure Medical · Oct 3, 2025 · DEN220077

FDA cleared the ProSense System from Icecure Medical on Oct 3, 2025 under DEN220077, a direct 510(k). The device falls under product code QXW, Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer, regulated at 21 CFR 878.4355 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Oct 19, 2022. The decision came 1080 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Icecure Medical has one other decision in the tracker over the last 12 months: K260377 (XSense Cryoablation System with CryoProbes).

Questions & Answers

What did FDA clear under DEN220077?

DEN220077 is the FDA 510(k) for ProSense System, submitted by Icecure Medical. FDA's decision date was Oct 3, 2025, under product code QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer).

Who makes the ProSense System?

Icecure Medical, based in Caesarea, is the applicant of record for DEN220077.

How long did the DEN220077 review take?

FDA received the submission on Oct 19, 2022 and issued its decision on Oct 3, 2025, 1080 days later.

← All decisions in October 2025

Sources