Sonata Sonography-Guided Transcervical Fibroid Ablation System— 510(k) K173703

Substantially Equivalent

Gynesonics, Inc.

FDA 510(k) clearance K173703 for Sonata Sonography-Guided Transcervical Fibroid Ablation System, Substantially Equivalent on 2018-08-15. Applicant: Gynesonics, Inc..

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Advisory panel: Obstetrics/Gynecology
Date received: 2017-12-04
Decision date: 2018-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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