510(k) Report

Devices descending from K193516

5 later devices reach Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+2K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+3K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+4K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+5K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—