510(k) K123865 ยท GEH Unit, Cryosurgical, Accessories
VISUAL-ICE CRYOABLATION SYSTEM
| Applicant | Galil Medical, Inc., Fulshear TX, US |
| Decision | Substantially Equivalent, Feb 6, 2013 |
| Received | Dec 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123865
| 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.