510(k) Report

Devices descending from K211535

4 later devices reach Sonata Transcervical Fibroid Ablation System 2.2 through their predicates, nearest generation first.

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