# K012497: Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Oct 30, 2001 after 88 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: 3 generations back to K980913 (1998). 3 ancestors in all.
29 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)
- K993965: Cryo-Hit, Galil Medical, Ltd. (2000) Summary page 3.
- (no number) Cryomedics, Neurostat: named in the summary without a submission number
- (no number) Spembly Lloyd Neurostat: 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

## Recalls of this device
- Dec 11, 2007 · Not classified · Z-1698-2008: The warming catheter was manufactured with the inlet and outlet tubes switched.

## Indications for use
The 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 (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 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 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 dysplasia of the female genitalia) General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.) ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids) The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Source page: https://510kreport.com/device/K012497
Methodology: https://510kreport.com/methodology