510(k) Report

Devices descending from K094009

10 later devices reach Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121858The Ablation SystemHalt Medical, Inc.20129—
+2K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+2K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+2K132184Acessa Guidance HandpieceHalt Medical, Inc.20140—
+3K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+4K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+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—