Sonata Transcervical Fibroid Ablation System 2.2— 510(k) K222304

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K222304 for Sonata Transcervical Fibroid Ablation System 2.2, Substantially Equivalent on 2022-11-08. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Advisory panel: Obstetrics/Gynecology
Date received: 2022-08-01
Decision date: 2022-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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