Cleared Traditional

Sonata? Sonography-Guided Transcervical Fibroid Ablation System 2.1

K193516 · Gynesonics, Inc. · Obstetrics & Gynecology
May 2020
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K193516 is an FDA 510(k) clearance for the Sonata? Sonography-Guided Transcervical Fibroid Ablation System 2.1, a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF), submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 4, 2020, 137 days after receiving the submission on December 19, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K193516 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2019
Decision Date May 04, 2020
Days to Decision 137 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code KNF — Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4160

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