Not Cleared Direct

DEN220077 - ProSense™ System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220077 · Icecure Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
1080d
Days
Class 2
Risk

DEN220077 is an FDA 510(k) submission (not cleared) for the ProSense™ System. Classified as Cryoablation Device For Local Treatment Of Low-risk Breast Cancer (product code QXW), Class II - Special Controls.

Submitted by Icecure Medical (Caesarea, IL). The FDA issued a Not Cleared (DENG) decision on October 3, 2025 after a review of 1080 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4355 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1080 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Icecure Medical devices

Submission Details

510(k) Number DEN220077 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 19, 2022
Decision Date October 03, 2025
Days to Decision 1080 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
966d slower than avg
Panel avg: 114d · This submission: 1080d
Pathway characteristics

Device Classification

Product Code QXW Cryoablation Device For Local Treatment Of Low-risk Breast Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4355
Definition A Cryoablation Device For Local Treatment Of Low-risk Breast Cancer Is A Prescription Device That Uses Cold Temperatures To Destroy A Breast Tumor And Its Surrounding Tissue. The Device Is Intended As A Local Treatment And May Be Used With Adjuvant Therapies (e.g., Endocrine Therapy, Radiation Therapy) To Reduce The Risk Of Local Disease Progression. The Device Is Intended For Use In Patients With A Well-defined Solid Tumor (e.g., Invasive Ductal Carcinoma) And With Low Risk Of Recurrence And Metastasis, As Determined By Clinical Risk Factors Consistent With The Indications For Use. The Device Is Not Intended To Treat Breast Cancers With High Risk Of Local Recurrence (e.g., Lobular Carcinoma), Patients With Aggressive Forms Of Breast Cancer (e.g., Breast Cancers With Inflammatory Features), Or Patients In Whom Targeted Systemic Therapy Is Indicated.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.