# K113860: Visual-Ice Cryoablation System

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Inc.
- Decided: Mar 12, 2012 after 73 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (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). 14 ancestors in all.
15 later devices descend from it; 5 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)
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera, Galil Medical, Ltd. (2006) Summary page 1.

## Most influential descendants
- K123865: Visual-Ice Cryoablation System (2013), 11 descendants of its own
- K143564: Visual-ICE Cryoablation System, Software Revision 1.3.1 (2015), 10 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

## Recalls of this device
- Oct 25, 2019 · Class II · Z-0404-2020: Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
- Jul 20, 2012 · Class II · Z-2261-2012: Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.

## Indications for use
The Visual-ICE h Crycablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, 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, skin lesions, and warts. 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) *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 condylomata, 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 fibroadenoma) *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/K113860
Methodology: https://510kreport.com/methodology