510(k) K113860 ยท GEH Unit, Cryosurgical, Accessories
VISUAL-ICE CRYOABLATION SYSTEM
| Applicant | Galil Medical, Inc., Lake Jackson TX, US |
| Decision | Substantially Equivalent, Mar 12, 2012 |
| Received | Dec 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113860
| 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 |
| Aug 23, 2012 | Galil Medical, Inc. Visual-ICE Cryoablation System, Model FPRCH 6000
Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedure Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.