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Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193516

by Gynesonics, Inc.

Identifiers

510(k) Number
K193516 FDA 510(k)
FDA Product Code
KNF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.4160 FDA 510(k)
Regulation Number
884.4160 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1 is a transcervical device designed for the ablation of uterine fibroids under sonographic guidance. It combines imaging and energy delivery to target and treat fibroid tissue while preserving surrounding structures, utilising a unipolar coagulator-cutter mechanism for precise intervention.

This system is intended for use in an outpatient or hospital setting, where it is supplied as a reusable or disposable kit, depending on component specifications. Sterility and MRI safety are critical considerations, with components adhering to regulatory standards for gynecological procedures. The system is authorised under FDA 510K and MDR, with a classification as a Class II device, and includes multiple registration numbers for compliance tracking.

Frequently asked questions

How is the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 supplied, and is it reusable or disposable?

The Sonata® system is supplied as either a reusable or disposable kit, depending on the specific components included. This flexibility allows clinicians to choose based on their facility’s protocols and preferences for infection control and workflow efficiency. The system is designed for use in both outpatient and hospital settings, ensuring compatibility with various clinical environments.

What types of energy does the Sonata® system use to ablate fibroids, and how does it ensure precision during the procedure?

The Sonata® system employs a unipolar coagulator-cutter mechanism to deliver energy for fibroid ablation. This method combines imaging guidance with targeted energy delivery, allowing clinicians to visualize the fibroid tissue in real-time via sonography while precisely ablating only the targeted area. This minimizes damage to surrounding healthy tissue, enhancing safety and effectiveness.

Are any components of the Sonata® system MRI-safe, and what considerations should be made for sterility?

MRI safety is a critical consideration for the Sonata® system, as it is designed for use in environments where MRI compatibility may be required. While the exact MRI safety classification of individual components isn’t detailed here, the system adheres to regulatory standards for gynecological procedures, ensuring compliance with safety protocols. Sterility is also emphasized, as the system is intended for clinical use where infection control is paramount, particularly in transcervical procedures.

What regulatory pathways does the Sonata® system follow, and how does this impact its use in clinical settings?

The Sonata® system is authorized under FDA 510K clearance and MDR (Medical Device Regulation), classifying it as a Class II device. This regulatory route ensures it meets stringent safety and performance standards before clinical use. The system’s classification as a coagulator-cutter, endoscopic, unipolar device (with associated product codes) reflects its specialized purpose in gynecological ablation procedures, guiding its adoption in obstetrics/gynecology settings where such precision tools are required.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gynesonics, Inc.

Sources (2)

  • FDA 510(k) K193516 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026