510(k) K152133 ยท GEH Unit, Cryosurgical, Accessories
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
| Applicant | Galil Medical , Ltd., Shaar Yokneam, IL |
| Decision | Substantially Equivalent, Aug 28, 2015 |
| Received | Jul 31, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX 90 Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX Cryoablation Needle Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation Three IceFORCE" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation Three IcePearl" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pro Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgi Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surg Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IcePearl2.1 CX ProstateKit Visual Ice System, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgic Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction o Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of t Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pr Terminated |
GEH | None listed |
| Jun 4, 2020 | Boston Scientific Corporation Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only
Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical pr Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.