510(k) K181741 ยท GEH Unit, Cryosurgical, Accessories
IceSphere 1.5 CX Cryoablation Needle
| Applicant | Galil Medical , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jul 30, 2018 |
| Received | Jul 2, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 CX 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.