510(k) K060144 ยท GEH Unit, Cryosurgical, Accessories
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
| Applicant | Galil Medical , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Feb 13, 2006 |
| Received | Jan 19, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 90 Cryoablation Needle Completed |
GEH | None listed |
| May 16, 2012 | Galil Medical, Inc. Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO.
Product Usage:
Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medic Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.