Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System.
The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy.
“Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO of Gynesonics, said in a press release. “We are focused now on responding to any questions or requests from the FDA in support of a timely submission review, and preparations for initial commercial launch in the U.S. in 2018.”