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FDA 510(k)

Sonata Transcervical Fibroid Ablation System 2.2

K-Number: K250705 · 2025-04-02

ApplicantGynesonics, Inc.
Decision Date2025-04-02
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sonata Transcervical Fibroid Ablation System 2.2 is a medical device manufactured by Gynesonics, Inc.. It received FDA 510(k) clearance on 2025-04-02 under approval number K250705. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonata Transcervical Fibroid Ablation System 2.2?

Sonata Transcervical Fibroid Ablation System 2.2 is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Gynesonics, Inc.. The 510(k) number is K250705.

When was Sonata Transcervical Fibroid Ablation System 2.2 approved by the FDA?

Sonata Transcervical Fibroid Ablation System 2.2 received FDA 510(k) clearance on 2025-04-02, under approval number K250705.

What company makes Sonata Transcervical Fibroid Ablation System 2.2?

Sonata Transcervical Fibroid Ablation System 2.2 is manufactured by Gynesonics, Inc..

What is the FDA product code for Sonata Transcervical Fibroid Ablation System 2.2?

The FDA product code for Sonata Transcervical Fibroid Ablation System 2.2 is KNF.

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Other Devices by Gynesonics, Inc.

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation System K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 K211535Sonata Transcervical Fibroid Ablation System 2.2 K222304Sonata Transcervical Fibroid Ablation System 2.2 K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) K240503Sonata Transcervical Fibroid Ablation System 2.2

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Related Devices (Code: KNF)

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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