Sonata Transcervical Fibroid Ablation System 2.2
K-Number: K211535 · 2021-06-17
Device Summary
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. The listed applicant is Gynesonics, Inc.. The 510(k) number is K211535.
When did Sonata Transcervical Fibroid Ablation System 2.2 receive FDA 510(k) clearance?
Sonata Transcervical Fibroid Ablation System 2.2 received FDA 510(k) clearance on 2021-06-17, under 510(k) number K211535.
Who is the listed applicant for Sonata Transcervical Fibroid Ablation System 2.2?
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 Transcervical Fibroid Ablation System 2.2?
The FDA product code for Sonata Transcervical Fibroid Ablation System 2.2 is KNF.
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.
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.
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.