Gynesonics submits 510(k) premarket notification for uterine fibroid treatment

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