510(k) K143625 ยท GEH Unit, Cryosurgical, Accessories
truFreeze System
| Applicant | CSA Medical, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Jan 15, 2015 |
| Received | Dec 22, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | CSA Medical CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device
Model: CC3-01 Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.