# K234002: ICEfx Cryoablation System (FPRCH8000-02)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Mar 13, 2024 after 85 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K010991 (2001). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230551: Visual-ICE Cryoablation System, Boston Scientific Corporation (2023) Summary page 5.

## Recalls of this device
- Aug 18, 2025 · Class II · Z-2551-2025: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Aug 18, 2025 · Class II · Z-2550-2025: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

## Indications for use
The ICEfx™ Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures. The ICEfx Cryoablation System has the following specific indications: • Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) • Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy. • Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Destruction of warts or lesions, 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, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin • Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia • General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas • ENT - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth • Thoracic surgery - (with the exception of cardiac tissue) • Proctology - Ablation of benign or malignant growths of the anus or rectum

Source page: https://510kreport.com/device/K234002
Methodology: https://510kreport.com/methodology