Gynesonics, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Sonata Transcervical Fibroid Ablation System 2.2510(k)Apr 2, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Apr 2, 2025
Sonata Transcervical Fibroid Ablation System 2.2510(k)Jul 17, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)510(k)Dec 21, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Dec 21, 2023
Sonata Transcervical Fibroid Ablation System 2.2510(k)Nov 8, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2022
Sonata Transcervical Fibroid Ablation System 2.2510(k)Jun 17, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Jun 17, 2021