510(k) K143564 ยท GEH Unit, Cryosurgical, Accessories
Visual-ICE Cryoablation System, Software Revision 1.3.1
| Applicant | Galil Medical, Inc., Arden Hills MN, US |
| Decision | Substantially Equivalent, Mar 5, 2015 |
| Received | Dec 16, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2019 | Galil Medical, Inc. Visual-ICE Cryoablation System, FPRCH6000.
The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.