510(k) K012497 ยท GEH Unit, Cryosurgical, Accessories
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Oct 30, 2001 |
| Received | Aug 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2008 | Galil Medical Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue. Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.