# K141485: Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Jul 2, 2014 after 27 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 3 (0 Class I)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera, Galil Medical, Ltd. (2006) Summary page 1.
- K021261: Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3, Galil Medical, Ltd. (2002) Summary page 1.
- K113860: Visual-Ice Cryoablation System, Galil Medical, Inc. (2012) Summary page 1.
- K110946: Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle, Galil Medical, Ltd. (2011) Summary page 1.

## Most influential descendants
- K181741: IceSphere 1.5 CX Cryoablation Needle (2018), 2 descendants of its own
- 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-0670-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0671-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0672-2021: Complaint trend regarding needle shaft gas leaks.

## Indications for use
Galil Medical Cryoablation Systems are intended for crycablative destruction of tissue during surgical procedures. The crycablation systems Is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, prodiology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Gauil Medical Crycablation Systems have the following specific indications: * Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (EPH) * 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, peni-anal condylomnata, and palliation of tumors of the skin * Gynecology Ablation of malignant neoplasia or benign dlysplasia of the female genitalia * General surgery Palliation of tumors of the rectum, hemorrhoids, 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 Ablation of arrhythmic cardiac tissue cancerous lesions * Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Source page: https://510kreport.com/device/K141485
Methodology: https://510kreport.com/methodology