# K140584: Icerod CX Cryoablation Needle

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Mar 31, 2014 after 24 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: 7 generations back to K010991 (2001). 17 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack, Galil Medical, Ltd. (2012) Summary page 1.

## Most influential descendants
- 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 (2015), 13 descendants of its own
- K161480: R2 Dermal Cooling System (2016), 5 descendants of its own
- K153489: Cryocare CS Surgical System (2016), 5 descendants of its own
- K230551: Visual-ICE Cryoablation System (2023), 4 descendants of its own
- K201588: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (2020), 4 descendants of its own

## Indications for use
The Galil Medical IceRod CX Cryoablation Needle isintended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Crycablation Needle 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 systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IceRod CX Cryoablation Needle has the following specific indications: Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") Oincology (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 mali hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosas, cavernous hemanglomas, perianal 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, hemorrhoids, 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, and hemorrhoids)

Source page: https://510kreport.com/device/K140584
Methodology: https://510kreport.com/methodology