FDA.reportPublic FDA data

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
81
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06972077026716EvermedXIAMEN TAFT MEDICAL CO.,LTD.WSSLGWHLATTKITMET2026-05-15
06972077026723EvermedXIAMEN TAFT MEDICAL CO.,LTD.WSSLHFTRESTWWHLBLK2026-05-15
06972077026730EvermedXIAMEN TAFT MEDICAL CO.,LTD.WSSRHFTRESTWWHLBLK2026-05-15
06972077026891ADCOXIAMEN TAFT MEDICAL CO.,LTD.B103ALPBK2026-05-15
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, EllipsoidalVarian Medical Systems, Inc.PC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalVarian Medical Systems, Inc.PC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalVarian Medical Systems, Inc.PC-2.1EL2023-04-20
00810563022063ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalVarian Medical Systems, 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 KitVARIAN MEDICAL SYSTEMS, 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® SystemGALIL MEDICAL LTDFPRPR30082016-08-15
07290104830075IceSeed® Prostate Cryoablation Kit / Presice® System BOSTON SCIENTIFIC CORPORATIONFPRPR45182016-08-15
07290104830082IceRod® Prostate Cryoablation Kit / SeedNet® SystemGALIL MEDICAL LTDFPRPR30702016-08-15
07290104830099IceRod® He-Thaw Prostate Cryoablation Kit / Presice® System GALIL MEDICAL LTDFPRPR45702016-08-15
07290104830105IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® SystemGALIL MEDICAL LTDFPRPR40702016-08-15
07290104830181IceSeed® 1.5 Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR32012016-08-15
07290104830198IceRod® 1.5 Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR32032016-08-15
07290104830204IceRod® 1.5 i-Thaw® Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR4009 2016-08-15
07290104830211IceSphere® 1.5 Cryoablation NeedleGALIL MEDICAL LTDFPRPR32582016-08-15
07290104830235IceSeed® 1.5 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR32022016-08-15
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 NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR31922016-08-15
07290104830273IceRod® 1.5 MRI Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR31932016-08-15
07290104830280IceSeed® 1.5 MRI 90° Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR31942016-08-15
07290104830297IceRod® 1.5 MRI 90° Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR31952016-08-15
07290104830303Multi-Point 1.5 Thermal Sensor™ BOSTON SCIENTIFIC CORPORATIONFPRPR40102016-08-15
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 SetBOSTON SCIENTIFIC CORPORATIONFPRPR40032016-08-15
07290104830525Prostate Procedure TemplateGALIL MEDICAL LTDSPR0000182017-02-15
07290104830556IceSphere® 1.5 S 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35612016-08-15
07290104830563IceRod® 1.5 PLUS 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35082016-08-15
07290104830570IceRod® 1.5 PLUS Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35102016-08-15
07290104830587IceRod® 1.5 CX 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35332016-08-15
07290104830594IceEDGE® 2.4 90° Cryoablation Needle GALIL MEDICAL LTDFPRPR35062016-08-15
07290104830938IceSphere® 1.5 Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35582016-08-15
07290104830945IceSphere® 1.5 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35602016-08-15
07290104830983IceRod® i-Thaw® Prostate Cryoablation Kit / Visual-ICE® SystemBOSTON SCIENTIFIC CORPORATIONFPRPR35722016-08-15
07290104830990IcePearl® 2.1 CX 90° Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR36012016-08-15
07290104831003IceFORCE® 2.1 CX 90° Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR36022016-08-15
07290104831010IcePearl® 2.1 CX Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR36032016-08-15
07290104831027IceFORCE® 2.1 CX Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR36042016-08-15
07290104831034IceFORCE® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® SystemBOSTON SCIENTIFIC CORPORATIONFPRPR36052016-08-15
07290104831041IcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® SystemBOSTON SCIENTIFIC CORPORATIONFPRPR36062016-08-15
07290104831058Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® SystemBOSTON SCIENTIFIC CORPORATIONFPRPR36072016-08-15
07290104831065Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® SystemBOSTON SCIENTIFIC CORPORATIONFPRPR36082016-08-15
07290104831072IcePearl™ 2.1 CX L 90° Cryoablation Needle BOSTON SCIENTIFIC CORPORATIONFPRPR36172016-10-14
07290104831089IceFORCE™ 2.1 CX L 90° Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR36182016-10-14
07290104831133IceSphere™ 1.5 CX Cryoablation NeedleBOSTON SCIENTIFIC CORPORATIONFPRPR35732018-09-22
00868390000204V2 ICE Probe SLSANARUS TECHNOLOGIES, INC.VP06012016-09-06
00868390000228V2 ICE PROBESANARUS TECHNOLOGIES, INC.VP06002016-09-06
00810563020007PerCryo™ Varian Medical Systems, Inc.PCS-172016-07-31
00810563020014PerCryo™Varian Medical Systems, Inc.PCS-17R2016-07-31
00810563020021PerCryo™Varian Medical Systems, Inc.PCS-242016-07-31
00810563020038PerCryo™Varian Medical Systems, Inc.PCS-24L2016-07-31
00810563020045RenalCryo™Varian Medical Systems, Inc.RS-172016-07-31
00810563020052RenalCryo™Varian Medical Systems, Inc.RS-17L2016-07-31
00810563020069RenalCryo™Varian Medical Systems, Inc.RS-242016-07-31
00810563020076RenalCryo™Varian Medical Systems, Inc.RS-24L2016-07-31
00810563020083V-Probe™Varian Medical Systems, Inc.CVA24002016-07-31
00810563020106N/AVarian Medical Systems, Inc.CRYO-482016-07-31
00810563020113TempProbe™Varian Medical Systems, Inc.CRYO-54-F2016-07-31
00810563020120TempProbe™Varian Medical Systems, Inc.CRYO-55-F2016-07-31
00810563020250RenalCryo™Varian Medical Systems, Inc.R3.82016-07-31
00810563020267RenalCryo™Varian Medical Systems, Inc.R3.8L2016-07-31
00810563020380N/AVarian Medical Systems, Inc.CRYO-772016-07-31
00810563020397N/AVarian Medical Systems, Inc.CRYO-207-V2016-07-31
00810563020427N/AVarian Medical Systems, Inc.CRYO-204-V2016-07-31
00810563020489V-Probe™Varian Medical Systems, Inc.CVA2400RA2016-07-31