510(k) Report

Devices descending from K050347

12 later devices reach Modification to Cryocare CS Surgical System through their predicates, nearest generation first.

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