510(k) K141485 ยท GEH Unit, Cryosurgical, Accessories
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
| Applicant | Galil Medical , Ltd., Arden Hills MN, US |
| Decision | Substantially Equivalent, Jul 2, 2014 |
| Received | Jun 5, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 IceSphere" 1.5 S 90 Cryoablation Needle Completed |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.