Cleared Special

Sonata Transcervical Fibroid Ablation System 2.2

K250705 · Gynesonics, Inc. · Obstetrics & Gynecology
Apr 2025
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K250705 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 April 2, 2025, 23 days after receiving the submission on March 10, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K250705 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2025
Decision Date April 02, 2025
Days to Decision 23 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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