FDA.report

Cryosurgical set

Definition
A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.
GUDID devices
77
Last updated
2025-02-27 11:59:49

Related Product Codes

CodeDeviceSpecialtyClassDevices
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery275
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery22

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00191506055752IceSeed™BOSTON SCIENTIFIC CORPORATIONH74939683331702025-02-19
00191506055769IceSphere™BOSTON SCIENTIFIC CORPORATIONH74939684357302025-02-19
00191506055776IceRod™BOSTON SCIENTIFIC CORPORATIONH74939685353302025-02-19
00191506032678IceSeedBOSTON SCIENTIFIC CORPORATIONH74939672331002024-03-26
00191506032692IceSeedBOSTON SCIENTIFIC CORPORATIONH74939674331702024-03-26
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalENDOCARE, INC.PC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalENDOCARE, INC.PC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalENDOCARE, INC.PC-2.1EL2023-04-20
00810563022063ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalENDOCARE, INC.PC-2.1SL2023-04-20
008105630206702.4mm V-Probe™ Cryoprobe Right Angle with 12 ft Return Hose LengthVARIAN MEDICAL SYSTEMS, INC.DP35-0902-2102022-09-01
008105630216842.4mm V-Probe™ Cryoprobe Right Angle with 12 ft Return Hose Length- Lead freeVARIAN MEDICAL SYSTEMS, INC.DP35-0902-2112022-09-01
00810563020977Urethral Warming Catheter KitENDOCARE, INC.DP40-0141-1062022-02-03
07290104831195MultiPoint 1.5 Thermal SensorGALIL MEDICAL LTDFPRPR4020-022020-10-30
07290104831164MultiPoint 1.5 Thermal SensorGALIL MEDICAL LTDFPRPR40202020-08-14
07290016936223Warming System-unit, CryosurgicalUC-CARE LTDFPRMC000342017-11-15
07290104830068IceSeed® Prostate Cryoablation Kit / SeedNet® SystGALIL MEDICAL LTDFPRPR30082016-08-15
07290104830075IceSeed® Prostate Cryoablation Kit / Presice® SystGALIL MEDICAL LTDFPRPR45182016-08-15
07290104830082IceRod® Prostate Cryoablation Kit / SeedNet® SysteGALIL MEDICAL LTDFPRPR30702016-08-15
07290104830099IceRod® He-Thaw Prostate Cryoablation Kit / PresicGALIL MEDICAL LTDFPRPR45702016-08-15
07290104830105IceRod® i-Thaw® Prostate Cryoablation Kit / PresicGALIL MEDICAL LTDFPRPR40702016-08-15
07290104830181IceSeed® 1.5 Cryoablation NeedleGALIL MEDICAL LTDFPRPR32012016-08-15
07290104830198IceRod® 1.5 Cryoablation NeedleGALIL MEDICAL LTDFPRPR32032016-08-15
07290104830204IceRod® 1.5 i-Thaw® Cryoablation Needle GALIL MEDICAL LTDFPRPR4009 2016-08-15
07290104830211IceSphere® 1.5 Cryoablation NeedleGALIL MEDICAL LTDFPRPR32582016-08-15
07290104830235IceSeed® 1.5 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR32022016-08-15
07290104830242IceRod® 1.5 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR32042016-08-15
07290104830259IceSphere® 1.5 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR32602016-08-15
07290104830266IceSeed® 1.5 MRI Cryoablation NeedleGALIL MEDICAL LTDFPRPR31922016-08-15
07290104830273IceRod® 1.5 MRI Cryoablation NeedleGALIL MEDICAL LTDFPRPR31932016-08-15
07290104830280IceSeed® 1.5 MRI 90° Cryoablation Needle GALIL MEDICAL LTDFPRPR31942016-08-15
07290104830297IceRod® 1.5 MRI 90° Cryoablation Needle GALIL MEDICAL LTDFPRPR31952016-08-15
07290104830303Multi-Point 1.5 Thermal Sensor™ GALIL MEDICAL LTDFPRPR40102016-08-15
07290104830310Single-Point 1.5 Thermal Sensor™ MultiPackGALIL MEDICAL LTDFPRPR32122016-08-15
07290104830327Single-Point 1.5 90° Thermal Sensor™ MultiPack GALIL MEDICAL LTDFPRPR32062016-08-15
07290104830426IceSphere® Cryoablation Needle GALIL MEDICAL LTDFPRPR32612017-02-15
07290104830518Galil Medical Urethral Warming SetGALIL MEDICAL LTDFPRPR40032016-08-15
07290104830525Prostate Procedure TemplateGALIL MEDICAL LTDSPR0000182017-02-15
07290104830556IceSphere® 1.5 S 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR35612016-08-15
07290104830563IceRod® 1.5 PLUS 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR35082016-08-15
07290104830570IceRod® 1.5 PLUS Cryoablation NeedleGALIL MEDICAL LTDFPRPR35102016-08-15
07290104830587IceRod® 1.5 CX 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR35332016-08-15
07290104830594IceEDGE® 2.4 90⁰ Cryoablation Needle GALIL MEDICAL LTDFPRPR35062016-08-15
07290104830938IceSphere® 1.5 Cryoablation NeedleGALIL MEDICAL LTDFPRPR35582016-08-15
07290104830945IceSphere® 1.5 90° Cryoablation NeedleGALIL MEDICAL LTDFPRPR35602016-08-15
07290104830983IceRod® i-Thaw® Prostate Cryoablation Kit / VisualGALIL MEDICAL LTDFPRPR35722016-08-15
07290104830990IcePearl® 2.1 CX 90⁰ Cryoablation Needle GALIL MEDICAL LTDFPRPR36012016-08-15
07290104831003IceFORCE® 2.1 CX 90⁰ Cryoablation Needle GALIL MEDICAL LTDFPRPR36022016-08-15
07290104831010IcePearl® 2.1 CX Cryoablation Needle GALIL MEDICAL LTDFPRPR36032016-08-15
07290104831027IceFORCE® 2.1 CX Cryoablation Needle GALIL MEDICAL LTDFPRPR36042016-08-15
07290104831034IceFORCE® 2.1 CX Prostate Cryoablation Kit / VisuaGALIL MEDICAL LTDFPRPR36052016-08-15
07290104831041IcePearl® 2.1 CX Prostate Cryoablation Kit / VisuaGALIL MEDICAL LTDFPRPR36062016-08-15
07290104831058Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit GALIL MEDICAL LTDFPRPR36072016-08-15
07290104831065Three IcePearl® 2.1 CX Prostate Cryoablation KitViGALIL MEDICAL LTDFPRPR36082016-08-15
07290104831072IcePearl™ 2.1 CX L 90⁰ Cryoablation Needle GALIL MEDICAL LTDFPRPR36172016-10-14
07290104831089IceFORCE™ 2.1 CX L 90⁰ Cryoablation NeedleGALIL MEDICAL LTDFPRPR36182016-10-14
07290104831133IceSphere™ 1.5 CX Cryoablation NeedleGALIL MEDICAL LTDFPRPR35732018-09-22
00868390000204V2 ICE Probe SLSANARUS TECHNOLOGIES, INC.VP06012016-09-06
00868390000228V2 ICE PROBESANARUS TECHNOLOGIES, INC.VP06002016-09-06
00810563020007PerCryo™ ENDOCARE, INC.PCS-172016-07-31
00810563020014PerCryo™ENDOCARE, INC.PCS-17R2016-07-31
00810563020021PerCryo™ENDOCARE, INC.PCS-242016-07-31
00810563020038PerCryo™ENDOCARE, INC.PCS-24L2016-07-31
00810563020045RenalCryo™ENDOCARE, INC.RS-172016-07-31
00810563020052RenalCryo™ENDOCARE, INC.RS-17L2016-07-31
00810563020069RenalCryo™ENDOCARE, INC.RS-242016-07-31
00810563020076RenalCryo™ENDOCARE, INC.RS-24L2016-07-31
00810563020083V-Probe™ENDOCARE, INC.CVA24002016-07-31
00810563020106N/AENDOCARE, INC.CRYO-482016-07-31
00810563020113TempProbe™ENDOCARE, INC.CRYO-54-F2016-07-31
00810563020120TempProbe™ENDOCARE, INC.CRYO-55-F2016-07-31
00810563020250RenalCryo™ENDOCARE, INC.R3.82016-07-31
00810563020267RenalCryo™ENDOCARE, INC.R3.8L2016-07-31
00810563020380N/AENDOCARE, INC.CRYO-772016-07-31
00810563020397N/AENDOCARE, INC.CRYO-207-V2016-07-31
00810563020427N/AENDOCARE, INC.CRYO-204-V2016-07-31
00810563020489V-Probe™ENDOCARE, INC.CVA2400RA2016-07-31
00810563020496PerCryo™ ENDOCARE, INC.PCS-17RS2017-07-24