# K993965: Cryo-Hit

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Feb 18, 2000 after 87 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 K980913 (1998). 2 ancestors in all.
123 later devices descend from it; 3 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991517: Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Galil Medical, Ltd. (1999) Summary page 2.

## Most influential descendants
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own
- K012497: Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1 (2001), 29 descendants of its own

## Indications for use
The CRYO-HIT™ System for MRI 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. The CRYO-HIT™ System for MR, like the already cleared 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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) The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.

Source page: https://510kreport.com/device/K993965
Methodology: https://510kreport.com/methodology