510(k) K021261 ยท GEH Unit, Cryosurgical, Accessories
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Jul 3, 2002 |
| Received | Apr 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2011 | Galil Medical, Inc. SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblatio Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.