# K181741: IceSphere 1.5 CX Cryoablation Needle

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Jul 30, 2018 after 28 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010991 (2001). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141485: Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle, Galil Medical, Ltd. (2014) Summary page 4.
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack, Galil Medical, Ltd. (2012) Summary page 4.
- K140584: Icerod CX Cryoablation Needle, Galil Medical, Ltd. (2014) Summary page 4.

## 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
- 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

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0664-2021: Complaint trend regarding needle shaft gas leaks.

## Indications for use
The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual. For reference, the indications for use from the Galil Medical Cryoablation Systems User Manuals are provided below. The Galil Medical Cryoablation Systems are 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 systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Galil Medical Cryoablation Systems have 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 • 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 fibroadenoma • 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/K181741
Methodology: https://510kreport.com/methodology