# K010991: Seednet, Models FP6T5, FP5T5, FP5T3

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: May 3, 2001 after 30 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011950: Seednet, Model FP6T5, FP5T5, FP5T3 (2002), 33 descendants of its own
- 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

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0687-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 11, 2010 · Not classified · Z-0832-2011: This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong 

Source page: https://510kreport.com/device/K010991
Methodology: https://510kreport.com/methodology