Gynesonics, Inc. is one of 5511 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.
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