510(k) K111859 ยท GEH Unit, Cryosurgical, Accessories
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
| Applicant | Galil Medical, Inc., Lake Jackson TX, US |
| Decision | Substantially Equivalent, Oct 7, 2011 |
| Received | Jun 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceEDGE" 2.4 90p 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.