# K072883: Ice-Sense

- Pathway: 510(k) (Traditional)
- Applicant: Arbel Medical, Ltd.
- Decided: Dec 10, 2007 after 62 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: 2 generations back to K953637 (1995). 6 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970995: CMS Cryolite, Cryomedical Sciences, Inc. (1997) Summary page 2.
- K964336: CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680, Cryomedical Sciences, Inc. (1997). Our reading of the summary gave K964366, FDA’s number for Eagle Eyes (Mech-Tronic Precision Mfg., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cryomedical Sciences Accuprobe 610”.
- K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series, Cryomedical Sciences, Inc. (1997) Summary page 2.
- K980913: Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Galil Medical, Ltd. (1998) Summary page 2.

## Most influential descendants
- K102360: Icesence 3 (2010), 25 descendants of its own
- K133258: Trufreeze System (2014), 20 descendants of its own
- K143625: truFreeze System (2015), 19 descendants of its own
- K150920: truFreeze System (2015), 11 descendants of its own
- K152668: truFreeze System (2015), 10 descendants of its own

## Indications for use
The ICE-SENSE Tm device has the following indications for use: Urology * The system may be used to ablate prostatic tissue. * The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Oncology * The system may be used for ablation of cancerous or malignant tissue. * The system may be used for ablation of benign tumors. * The system may be used for palliative intervention. Dermatology · The system may be used for the ablation or freezing of skin cancers and other ctaneous disorders. Gynecology *The system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia. General Surgery * The system may be used for the ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar wadts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. * The system may be used for the destruction of warts or lesions. * The system may be used for the palliation of tumors of the oral cavity, rectum, and skin. ThoracicSrgr * The system may be used for the ablation of arrhythmic cardiac tissue. * The system may be used for the ablation of cancerous lesions Proctology * The system may be used for the ablation of benign or malignant growths of the anus and rectum * The systems may be used for the ablation of hemorrhoids

Source page: https://510kreport.com/device/K072883
Methodology: https://510kreport.com/methodology