Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1— 510(k) K193516

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K193516 for Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1, Substantially Equivalent on 2020-05-04. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Advisory panel: Obstetrics/Gynecology
Date received: 2019-12-19
Decision date: 2020-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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