Cleared Special

K233848 - Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K233848 is an FDA 510(k) clearance for the Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220). Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 21, 2023 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gynesonics, Inc. devices

Submission Details

510(k) Number K233848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d faster than avg
Panel avg: 160d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 43
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K233848.
Sonata Transcervical Fibroid Ablation System 2.2
K250705 · Gynesonics, Inc. · Apr 2025
Sonata Transcervical Fibroid Ablation System 2.2
K240503 · Gynesonics, Inc. · Jul 2024
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · Gynesonics, Inc. · Nov 2022
Sonata Transcervical Fibroid Ablation System 2.2
K211535 · Gynesonics, Inc. · Jun 2021