# K260377: XSense Cryoablation System with CryoProbes

- Pathway: 510(k) (Special)
- Applicant: IceCure Medical, Ltd.
- Decided: Feb 24, 2026 after 19 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K003811 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240892: XSense Cryoablation System with Cryoprobes, IceCure Medical, Ltd. (2024) Summary page 5.

## Indications for use
XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. XSense Cryoablation System with CryoProbes is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide real-time visualization of the cryosurgical procedure. The system has the following specific indications: Urology: Ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH). Oncology: Ablation of cancerous or malignant tissue and benign tumors and palliative intervention. Dermatology: Ablation or freezing of skin cancers and other cutaneous disorders. Palliation of tumors of the skin. Destruction of warts or lesions. Gynecology: Ablation of malignant neoplasia or benign dysplasia of the female genitalia. ENT (Ear, Nose, and Throat): Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth. General Surgery: Ablation of breast fibroadenomas, leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of tumors of the oral cavity, rectum, and skin. Thoracic Surgery: Ablation of arrhythmic cardiac tissue and cancerous lesions. Proctology: Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.

Source page: https://510kreport.com/device/K260377
Methodology: https://510kreport.com/methodology