Cleared Traditional

K240503 - Sonata Transcervical Fibroid Ablation System 2.2 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240503 · Gynesonics, Inc. · Obstetrics & Gynecology device
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Jul 2024
Decision
147d
Days
Class 2
Risk

K240503 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 July 17, 2024 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gynesonics, Inc. devices

Submission Details

510(k) Number K240503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2024
Decision Date July 17, 2024
Days to Decision 147 days
Submission Type Traditional
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
13d faster than avg
Panel avg: 160d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K240503.
Sonata Transcervical Fibroid Ablation System 2.2
K250705 · Gynesonics, Inc. · Apr 2025
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
Sonata Transcervical Fibroid Ablation System 2.2
K211535 · Gynesonics, Inc. · Jun 2021