Sonata Transcervical Fibroid Ablation System 2.2— 510(k) K211535

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K211535 for Sonata Transcervical Fibroid Ablation System 2.2, Substantially Equivalent on 2021-06-17. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Advisory panel: Obstetrics/Gynecology
Date received: 2021-05-18
Decision date: 2021-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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