510(k) Report

Devices descending from K043278

23 later devices reach Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+1K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+1K061153Gynesonics EC6 TransducerGynesonics, Inc.20067—
+1K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+2K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+2K141110Cryocare CS Surgical SystemHealthtronics20157—
+2K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+2K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+2K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+3K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+3K153489Cryocare CS Surgical SystemHealthtronics20165—
+3K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+3K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+4K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+4K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+5K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+5K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+5K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+5K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+5K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+6K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+7K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+8K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—