510(k) K121251 ยท GEH Unit, Cryosurgical, Accessories
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
| Applicant | Galil Medical , Ltd., Lake Jackson TX, US |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | Apr 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 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.