Sonata® Transcervical Fibroid Ablation System

Primary DI

10817929020333

Basic UDI-DI Code

081792902SONATAKA

Reference

SONATA2-220

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Gynesonics, Inc.

The Sonata® Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids. The Sonata System includes an RF Generator, ultrasound console SMART Tablet, and cart. Distributed with embedded software

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).