# K003065: Seednet, Model EP6T5, EP5E5

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Oct 31, 2000 after 29 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051052: Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System) (2005), 31 descendants of its own
- 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

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0676-2021: Complaint trend regarding needle shaft gas leaks.

Source page: https://510kreport.com/device/K003065
Methodology: https://510kreport.com/methodology