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FDA 510(k)

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

K-Number: K193516 · 2020-05-04

ApplicantGynesonics, Inc.
Decision Date2020-05-04
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is a medical device manufactured by Gynesonics, Inc.. It received FDA 510(k) clearance on 2020-05-04 under approval number K193516. 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® Sonography-Guided Transcervical Fibroid Ablation System 2.1?

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is a medical device that received FDA 510(k) clearance on 2020-05-04. It is manufactured by Gynesonics, Inc.. The 510(k) number is K193516.

When was Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 approved by the FDA?

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 received FDA 510(k) clearance on 2020-05-04, under approval number K193516.

What company makes Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1?

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is manufactured by Gynesonics, Inc..

What is the FDA product code for Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1?

The FDA product code for Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is KNF.

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Other Devices by Gynesonics, Inc.

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation System 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 K250705Sonata Transcervical Fibroid Ablation System 2.2

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Related Devices (Code: KNF)

K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, 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. K250705Sonata 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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