# K060144: Seednet/Seednetgold, Cryothera and Cryo-Hit Systems

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Feb 13, 2006 after 25 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 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® System: named in the summary without a submission number
- (no number) SeedNetGold® System: named in the summary without a submission number
- (no number) CryoThera® System: named in the summary without a submission number
- (no number) Cryo-Hit® System: named in the summary without a submission number
- (no number) Endocare CryoCare surgical system and accessories: named in the summary without a submission number

## Most influential descendants
- 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
- 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
- Nov 18, 2020 · Class II · Z-0668-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0675-2021: Complaint trend regarding needle shaft gas leaks.
- Apr 12, 2012 · Not classified · Z-1613-2012: Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.

## Indications for use
The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet Family 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, 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, 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 cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Source page: https://510kreport.com/device/K060144
Methodology: https://510kreport.com/methodology