Medical Device Manufacturer · US , Redwood City , CA

Gynesonics, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2006

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

FDA 510(k) Regulatory Record - Gynesonics, Inc. Obstetrics & Gynecology ✕

7 devices
1-7 of 7
Cleared Apr 02, 2025
Sonata Transcervical Fibroid Ablation System 2.2
K250705 · KNF
Obstetrics & Gynecology · 23d
Cleared Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
K240503 · KNF
Obstetrics & Gynecology · 147d
Cleared Dec 21, 2023
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
K233848 · KNF
Obstetrics & Gynecology · 16d
Cleared Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · KNF
Obstetrics & Gynecology · 99d
Cleared Jun 17, 2021
Sonata Transcervical Fibroid Ablation System 2.2
K211535 · KNF
Obstetrics & Gynecology · 30d
Cleared May 04, 2020
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
K193516 · KNF
Obstetrics & Gynecology · 137d
Cleared CT Aug 15, 2018
Sonata Sonography-Guided Transcervical Fibroid Ablation System
K173703 · KNF
Obstetrics & Gynecology · 254d
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