FDA.reportPublic FDA data

General cryosurgical system, cryogen gas, electronic

Definition
An assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.
GUDID devices
46
Last updated
2020-08-24 06:57:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810563020649Varian CRYOCARE TOUCH™ SystemVarian Medical Systems, Inc.CRYO-38T2020-08-14
00888937000016Her Option Coopersurgical, Inc.CG-12014-09-17
00859019006417ICEfx Cryoablation SystemBOSTON SCIENTIFIC CORPORATIONFPRCH8000-022020-02-24
00859019006462Visual-ICE® Cryoablation SystemBOSTON SCIENTIFIC CORPORATIONFPRCH6000-022020-02-24
07290104830020MRI SeedNet®Gold Cryoablation SystemGALIL MEDICAL LTDFPRCH20352016-08-15
07290104830884MRI Mobile UnitGALIL MEDICAL LTDFPRCH20302016-08-15
07290104830891MRI Mobile Unit for MRI CryoHit systemGALIL MEDICAL LTDFPRCH20322016-08-15
07290104830914MRI SeedNet®Gold ConsoleGALIL MEDICAL LTDFPRCH20332016-08-15
00859019006004EZ CONNECT2™ Dual Cylinder Adapter, psiGALIL MEDICAL INC.FPRCH40002016-08-15
00859019006011EZ CONNECT2™ Dual Cylinder Adapter, bar GALIL MEDICAL INC.FPRCH40012016-08-15
00859019006028Argon Supply Line (8 m), bar GALIL MEDICAL INC.FPRCH61002016-08-15
00859019006035Helium Supply Line (8 m), bar GALIL MEDICAL INC.FPRCH61012016-08-15
00859019006042Argon Supply Line (3 m), bar GALIL MEDICAL INC.FPRCH61032016-08-15
00859019006059Helium Supply Line (3 m), barGALIL MEDICAL INC.FPRCH61052016-08-15
00859019006066Argon Supply Line (8 m), psi GALIL MEDICAL INC.FPRCH61062016-08-15
00859019006073Helium Supply Line (8 m), psi GALIL MEDICAL INC.FPRCH61072016-08-15
00859019006080Argon Supply Line (5 m), psiGALIL MEDICAL INC.FPRCH61272016-08-15
00859019006097Argon Supply Line (5 m), barGALIL MEDICAL INC.FPRCH61282016-08-15
00859019006103Helium Supply Line (5 m), psiGALIL MEDICAL INC.FPRCH61292016-08-15
00859019006110Helium Supply Line (5 m), barGALIL MEDICAL INC.FPRCH61302016-08-15
00859019006127Gas Supply Line (5 m)GALIL MEDICAL INC.FPRCH61312016-08-15
00859019006134Gas Supply Line (8 m) GALIL MEDICAL INC.FPRCH61322016-08-15
00859019006141Argon Auxiliary Line (1.22 m) GALIL MEDICAL INC.FPRCH61332016-08-15
00859019006158Argon Supply Line (8 m), psiGALIL MEDICAL INC.FPRCH61372016-08-15
00859019006165Argon Supply Line (8 m), barGALIL MEDICAL INC.FPRCH61382016-08-15
00859019006172Helium Supply Line (8 m), psiGALIL MEDICAL INC.FPRCH61392016-08-15
00859019006189Helium Supply Line (8 m), barGALIL MEDICAL INC.FPRCH61402016-08-15
00859019006196EZ CONNECT2™ Dual Cylinder Adapter, psi BOSTON SCIENTIFIC CORPORATIONFPRCH40042016-08-15
00859019006202EZ CONNECT2™ Dual Cylinder Adapter, bar GALIL MEDICAL INC.FPRCH40052016-08-15
00859019006219EZ CONNECT2™ Dual Cylinder Adapter (8 m), psi GALIL MEDICAL INC.FPRCH40072016-08-15
00859019006226EZ CONNECT2™ Dual Cylinder Adapter (8 m), bar GALIL MEDICAL INC.FPRCH40082016-08-15
00859019006233Gas Supply Line (8 m) GALIL MEDICAL INC.FPRCH61082016-08-15
00859019006240Gas Supply Line (3 m) GALIL MEDICAL INC.FPRCH61092016-08-15
00859019006257Argon Auxiliary Line (3 m) GALIL MEDICAL INC.FPRCH61152016-08-15
00859019006264AR Supply Hose, 4.5m, barGALIL MEDICAL INC.FPRCH61182016-08-15
00859019006271AR Supply Hose, 4.5m, psiGALIL MEDICAL INC.FPRCH61192016-08-15
00859019006288HE Supply Hose, 4.5m, barGALIL MEDICAL INC.FPRCH61202016-08-15
00859019006295HE Supply Hose, 4.5m, psiGALIL MEDICAL INC.FPRCH61212016-08-15
00859019006301Supply Hose 4.5m w/o gaugeGALIL MEDICAL INC.FPRCH61242016-08-15
00859019006318Visual-ICE MRI Cryoablation ConsoleGALIL MEDICAL INC.FPRCH70002018-03-07
00859019006325Visual-ICE MRI Junction Box AssemblyGALIL MEDICAL INC.FPRCH7050 2018-03-07
00859019006332Visual-ICE MRI Mobile Connection PanelGALIL MEDICAL INC.FPRCH71002018-03-07
00859019006370ICEfx Cryoablation SystemGALIL MEDICAL INC.FPRCH80002018-08-01
00859019006387ICEfx Cryoablation System CartBOSTON SCIENTIFIC CORPORATIONFPRCH80102018-08-01
00867379000006Visual-ICE® Cryoablation SystemGALIL MEDICAL INC.FPRCH60002017-02-15
00868390000211Visica 2SANARUS TECHNOLOGIES, INC.VS30002016-09-06