510(k) K010991 ยท GEH Unit, Cryosurgical, Accessories
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, May 3, 2001 |
| Received | Apr 3, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Dec 29, 2010 | Galil Medical Urethral Warmer System Model number FPRCH3001
The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures whil Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.