510(k) K051052 ยท GEH Unit, Cryosurgical, Accessories
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, May 6, 2005 |
| Received | Apr 25, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 MRI 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 MRI Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 MRI 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 MRI Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" Prostate Cryoablation Kit Completed |
GEH | None listed |
| 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.