Gynesonics, Inc. is one of 16198 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gynesonics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sonata Transcervical Fibroid Ablation System 2.2, Sonata Transcervical Fibroid Ablation System 2.2, Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
8
Total
8
Cleared
0
Denied
Gynesonics, Inc. has 8 FDA 510(k) cleared medical devices. Based in Redwood City, US.
Latest FDA clearance: Apr 2025. Active since 2006. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Gynesonics, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Gynesonics, Inc.
8 devices
Cleared
Apr 02, 2025
Sonata Transcervical Fibroid Ablation System 2.2
Obstetrics & Gynecology
23d
Cleared
Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
Obstetrics & Gynecology
147d
Cleared
Dec 21, 2023
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
Obstetrics & Gynecology
16d
Cleared
Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
Obstetrics & Gynecology
99d
Cleared
Jun 17, 2021
Sonata Transcervical Fibroid Ablation System 2.2
Obstetrics & Gynecology
30d
Cleared
May 04, 2020
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Obstetrics & Gynecology
137d
Cleared
CT
Aug 15, 2018
Sonata Sonography-Guided Transcervical Fibroid Ablation System
Obstetrics & Gynecology
254d
Cleared
Oct 27, 2006
GYNESONICS EC6 TRANSDUCER
Radiology
184d