510(k) K162599 ยท GEH Unit, Cryosurgical, Accessories
IcePearl 2.1 CX L, IceForce 2.1 CX L
| Applicant | Galil Medical , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Oct 11, 2016 |
| Received | Sep 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX L 90 Cryoablation Needle Completed |
GEI | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX L 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.