Gynesonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250705Sonata Transcervical Fibroid Ablation System 2.2April 2, 2025
K240503Sonata Transcervical Fibroid Ablation System 2.2July 17, 2024
K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)December 21, 2023
K222304Sonata Transcervical Fibroid Ablation System 2.2November 8, 2022
K211535Sonata Transcervical Fibroid Ablation System 2.2June 17, 2021
K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1May 4, 2020
K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemAugust 15, 2018
K061153GYNESONICS EC6 TRANSDUCEROctober 27, 2006