510(k) Report

Devices descending from K002615

14 later devices reach Surgical System with Cryoguide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+1K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+2K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+2K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+3K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+4K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+5K141110Cryocare CS Surgical SystemHealthtronics20157—
+6K153489Cryocare CS Surgical SystemHealthtronics20165—
+6K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+7K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+8K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+8K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+8K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+8K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—