510(k) Report

Devices descending from K222304

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

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