# K011950: Seednet, Model FP6T5, FP5T5, FP5T3

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Jan 29, 2002 after 222 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: 1 generation back to K010991 (2001). 1 ancestor in all.
33 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010991: Seednet, Models FP6T5, FP5T5, FP5T3, Galil Medical, Ltd. (2001) Summary page 3.
- (no number) Cryo-Hit™: named in the summary without a submission number
- (no number) Cryo-Mono with TUF Probe: named in the summary without a submission number

## Most influential descendants
- K021261: Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 (2002), 32 descendants of its own
- K031117: Seednet System and Seednetgold System (2003), 31 descendants of its own
- K042667: Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold) (2004), 29 descendants of its own
- 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

## 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, 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 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 arrthythmic cardiac tissue, and ablation of cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

Source page: https://510kreport.com/device/K011950
Methodology: https://510kreport.com/methodology