Cleared Special

K211535 - Sonata Transcervical Fibroid Ablation System 2.2 (FDA 510(k) Clearance)

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

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

K211535 is an FDA 510(k) clearance for the Sonata Transcervical Fibroid Ablation System 2.2. 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 June 17, 2021 after a review of 30 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 K211535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · This submission: 30d
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 K211535.
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 (SONATA2-220)
K233848 · Gynesonics, Inc. · Dec 2023
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · Gynesonics, Inc. · Nov 2022