510(k) K110946 ยท GEH Unit, Cryosurgical, Accessories
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
| Applicant | Galil Medical , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jun 21, 2011 |
| Received | Apr 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110946
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 PLUS 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 PLUS 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.