510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QXWClass II

Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer

21 CFR 878.4355 / General, Plastic Surgery
FDA source (opens on fda.gov)

QXW is the FDA product code for Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer, a class II device type, regulated under 21 CFR 878.4355. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXW
Device name
Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
FDA 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.
Regulation
21 CFR 878.4355
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXW

By decision year
1 clearance under product code QXW with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXW by decision year
YearClearances
20251

Applicants with the most clearances

Product code QXW
Applicants holding the most 510(k) clearances under product code QXW
ApplicantClearances
Icecure Medical Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code