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FDA 510(k)

Sonata Transcervical Fibroid Ablation System 2.2

K-Number: K211535 · 2021-06-17

ApplicantGynesonics, Inc.
Decision Date2021-06-17
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 2021-06-17 under approval number K211535. 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 2021-06-17. It is manufactured by Gynesonics, Inc.. The 510(k) number is K211535.

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 2021-06-17, under approval number K211535.

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 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. K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, 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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