510(k) Report

Devices descending from K061153

7 later devices reach Gynesonics EC6 Transducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+2K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+3K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+4K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+5K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+6K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+7K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—