# K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Aug 28, 2012 after 125 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: 6 generations back to K010991 (2001). 16 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110946: Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle, Galil Medical, Ltd. (2011) Summary page 1.
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera, Galil Medical, Ltd. (2006) Summary page 1.

## Most influential descendants
- K140584: Icerod CX Cryoablation Needle (2014), 20 descendants of its own
- 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
- K143564: Visual-ICE Cryoablation System, Software Revision 1.3.1 (2015), 10 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

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0663-2021: Complaint trend regarding needle shaft gas leaks.

## Indications for use
The Gal ii Medical IceRod CX Cryoablation Needle is intended for crycablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation 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") *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 hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomnata, 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/K121251
Methodology: https://510kreport.com/methodology