510(k) K133258 ยท GEH Unit, Cryosurgical, Accessories
TRUFREEZE SYSTEM
| Applicant | CSA Medical, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Jun 19, 2014 |
| Received | Oct 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2015 | CSA Medical CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device
***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.