Cleared Special

Sonata Transcervical Fibroid Ablation System 2.2

K211535 · Gynesonics, Inc. · Obstetrics & Gynecology
Jun 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K211535 is an FDA 510(k) clearance for the Sonata Transcervical Fibroid Ablation System 2.2, 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 June 17, 2021, 30 days after receiving the submission on May 18, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K211535 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2021
Decision Date June 17, 2021
Days to Decision 30 days
Submission Type Special
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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