510(k) K060390 ยท GEH Unit, Cryosurgical, Accessories
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Apr 27, 2006 |
| Received | Feb 14, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 i-Thaw" Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" i-Thaw" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" i-Thaw" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" He-Thaw Prostate Cryoablation Kit Completed |
GEH | None listed |
| Feb 3, 2011 | Galil Medical, Inc. Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation syst Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.