FDA product code QXW: Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
QXW is the FDA product code for cryoablation device for local treatment of low-risk breast cancer. It is a Class II device, regulated under 21 CFR 878.4355 and reviewed by the General and Plastic Surgery panel. Devices under QXW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer |
| Device class | Class II |
| Regulation | 21 CFR 878.4355 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QXW devices
openFDA lists no recalls for product code QXW.
Frequently asked questions
What is FDA product code QXW?
QXW is the FDA product code for cryoablation device for local treatment of low-risk breast cancer. It is a Class II device, regulated under 21 CFR 878.4355 and reviewed by the General and Plastic Surgery panel.
What device class is QXW?
Class II, regulation 21 CFR 878.4355. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXW
- Run a recall and safety report across every QXW manufacturer
- Watch product code QXW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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