FDA Product Code QXW: Cryoablation Device For Local Treatment Of Low-risk Breast Cancer
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.
Leading manufacturers include Icecure Medical.
FDA 510(k) Cleared Cryoablation Device For Local Treatment Of Low-risk Breast Cancer Devices (Product Code QXW)
About Product Code QXW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QXW since 2025, with 0 receiving FDA clearance (average review time: 1080 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QXW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →