# K991272: Cryo-Hit,Models ED1TO, Epiti, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,and E

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Jul 12, 1999 after 90 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: 1 generation back to K980913 (1998). 1 ancestor in all.
29 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980913: Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Galil Medical, Ltd. (1998) Summary page 2.
- (no number) ENDOcare: named in the summary without a submission number

## Most influential descendants
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera (2006), 28 descendants of its own
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack (2012), 22 descendants of its own
- K140584: Icerod CX Cryoablation Needle (2014), 20 descendants of its own
- K113860: Visual-Ice Cryoablation System (2012), 15 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

## Indications for use
The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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. In addition the modified CRYO-HIT™ 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 ablation of benign tumors, and palliative intervention) Dermatology (ablation or freezing of skin cancers and other cutaneous disorders) Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the 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 warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, and recurrent cancerous lesions) Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

Source page: https://510kreport.com/device/K991272
Methodology: https://510kreport.com/methodology