510(k) Report

Devices descending from K011074

56 later devices reach Cryocare Surgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141110Cryocare CS Surgical SystemHealthtronics20157—
+1K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc.20062—
+1K023757Cryocare Surgical System, Model Cryo 20Endocare, Inc.2002542
+2K153489Cryocare CS Surgical SystemHealthtronics20165—
+2K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+2K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+2K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+2K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+3K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+3K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+3K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+3K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+3K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+3K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+3K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+3K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+3K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+4K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+4K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+4K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+4K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+4K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+4K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+4K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+4K133821Emprint Ablation SystemCovidien, LLC2014297
+4K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+5K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+5K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+5K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+5K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+5K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+5K181941Swift SystemEmblation, Ltd.20183—
+5K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+5K163105Emprint Ablation SystemCovidien, LLC2016133
+5K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+6K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+6K222388swiftPro SystemEmblation, Ltd.20232—
+6K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+6K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+6K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+6K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+6K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+6K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+6K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+7K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+7K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+7K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+7K240518swiftPro™ SystemEmblation Limited20241—
+7K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+7K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+7K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+7K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+7K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+8K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+8K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+8K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—