K173703 is an FDA 510(k) clearance for the Sonata Sonography-Guided Transcervical Fibroid Ablation System. 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 August 15, 2018 after a review of 254 days - an extended review cycle.
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
NCT02228174
Completed
Interventional
Industry-sponsored
Sonography Guided Transcervical Ablation of Uterine Fibroids
Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
| Condition studied |
Menorrhagia |
| Study design |
Single group |
| Eligibility |
Female only
· 25 Years+
|
| Sponsor |
Gynesonics
(industry)
|
Started 2014-10-01
→
Primary completion 2017-10-18
→
Completed 2019-11-01
Primary outcome
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
Secondary outcome
Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
View full study on ClinicalTrials.gov