# K230551: Visual-ICE Cryoablation System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 8, 2023 after 161 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: 9 generations back to K010991 (2001). 25 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113860: Visual-Ice Cryoablation System, Galil Medical, Inc. (2012) Summary page 5.
- K143564: Visual-ICE Cryoablation System, Software Revision 1.3.1, Galil Medical, Inc. (2015) Summary page 5.
- K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System, Galil Medical, Ltd. (2015) Summary page 5.

## Most influential descendants
- K232635: IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) (2023), 1 descendant of its own
- K250742: Focused Cryotherapy System (2025), 0 descendants of its own
- K243245: IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (2024), 0 descendants of its own
- K234002: ICEfx Cryoablation System (FPRCH8000-02) (2024), 0 descendants of its own

## Indications for use
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ 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. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, and skin lesions. The Visual-ICE 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/K230551
Methodology: https://510kreport.com/methodology