# K051052: Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: May 6, 2005 after 11 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003065 (2000). 1 ancestor in all.
31 later devices descend from it; 2 cite 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)
- K003065: Seednet, Model EP6T5, EP5E5, Galil Medical, Ltd. (2000) Summary page 1.
- (no number) Cryo-Hit System: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K003117: SeedNet System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera (2006), 28 descendants of its own
- K110946: Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle (2011), 25 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
- K111859: Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle Multipack (2011), 19 descendants of its own

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0669-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0680-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0678-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0679-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0681-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0688-2021: Complaint trend regarding needle shaft gas leaks.
- Dec 20, 2010 · Not classified · Z-1032-2011: This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across t

## Indications for use
The SeedNet 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 SeedNet 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 SeedNet 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/K051052
Methodology: https://510kreport.com/methodology