# K243042: Co-Ablation System with Sterile Co-Ablation Probe

- Pathway: 510(k) (Traditional)
- Applicant: Hygea Medical Technology Co., Ltd.
- Decided: Jan 29, 2025 after 124 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: 13 generations back to K926514 (1993). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201588: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice, Varian Medical Systems, Inc. (2020) Summary page 6.
- K240892: XSense Cryoablation System with Cryoprobes, IceCure Medical, Ltd. (2024) Summary page 6.
- K230271: ISOLIS Cryoprobe, Varian Medical Systems, Inc. (2023) Summary page 6.

## Indications for use
The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is also intended for use in the following indications: General Surgery • Destruction of warts or lesions. • Palliation of tumors of the oral cavity, rectum, and skin. • Ablation of breast fibroadenomas. • Ablation of 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. Urology • Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia. Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia. Oncology • Ablation of cancerous or malignant tissue. • Ablation of benign tumors. • Palliative intervention. Neurology • Freezing of nerve tissue in pain management/cryoanalgesia. Dermatology • Ablation or freezing of skin cancers and other cutaneous disorders. Proctology • Ablation of benign or malignant growths of the anus and rectum. • Ablation of hemorrhoids. Thoracic Surgery • Ablation of cancerous lesions.

Source page: https://510kreport.com/device/K243042
Methodology: https://510kreport.com/methodology