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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 the device name listed in this FDA 510(k) record. The listed applicant is Gynesonics, Inc.. It received FDA 510(k) clearance on 2020-05-04 under 510(k) 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. The listed applicant is Gynesonics, Inc.. The 510(k) number is K193516.

When did Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1?

The FDA 510(k) record lists Gynesonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02386137Factors Influencing Volumetric MR-HIFU Ablation of Uterine FibroidsCOMPLETEDNCT04345003MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine FibroidsCOMPLETED

Other records listing Gynesonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250705Sonata Transcervical Fibroid Ablation System 2.2K240503Sonata Transcervical Fibroid Ablation System 2.2K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)K222304Sonata Transcervical Fibroid Ablation System 2.2K211535Sonata Transcervical Fibroid Ablation System 2.2K173703Sonata Sonography-Guided Transcervical Fibroid Ablation System

View all 7 devices →

Related Devices (Code: KNF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, 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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