# K052530: Seednet, Seednet Gold, Cryohit, Cryothera

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Nov 18, 2005 after 65 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
No predicates in its family tree.
54 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SeedNet Family: named in the summary without a submission number
- (no number) CryoCare CS system: named in the summary without a submission number
- (no number) Visica system: named in the summary without a submission number

## Most influential descendants
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera (2006), 28 descendants of its own
- K102360: Icesence 3 (2010), 25 descendants of its own
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack (2012), 22 descendants of its own
- K133258: Trufreeze System (2014), 20 descendants of its own
- K140584: Icerod CX Cryoablation Needle (2014), 20 descendants of its own

## Indications for use
The SeedNet Family 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 SeedNet Family 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, angiomtas, 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, ablation of breast fibroadenomas.) 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 SeedNet Family 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/K052530
Methodology: https://510kreport.com/methodology