Sonata® Transcervical Fibroid Ablation System
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- 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.
Additional Description
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
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12080299 | GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).