Sonata Transcervical Fibroid Ablation System 2.2— 510(k) K250705

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K250705 for Sonata Transcervical Fibroid Ablation System 2.2, Substantially Equivalent on 2025-04-02. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Advisory panel: Obstetrics/Gynecology
Date received: 2025-03-10
Decision date: 2025-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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