Cleared Special

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

K233848 · Gynesonics, Inc. · Obstetrics & Gynecology
Dec 2023
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K233848 is an FDA 510(k) clearance for the Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220), 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 December 21, 2023, 16 days after receiving the submission on December 5, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K233848 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2023
Decision Date December 21, 2023
Days to Decision 16 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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