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

Name: FDA 510(k) clearance K193516
Creator: U.S. Food and Drug Administration
Published: 2020-05-04

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.. Device class: 2.

Clearance details

Applicant: Gynesonics, Inc.
Product code: Code KNF
Device class: Class 2
Regulation: 21 CFR 884.4160
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

Download summary PDF View on FDA.gov ↗

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K222304 — Sonata Transcervical Fibroid Ablation System 2.22022-11-08
K211535 — Sonata Transcervical Fibroid Ablation System 2.22021-06-17

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K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System2018-08-15
K061153 — GYNESONICS EC6 TRANSDUCER2006-10-27

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