Class Class II
Sonata Transcervical Fibroid Ablation System 2.2 (K240503)
Description
Sonata Transcervical Fibroid Ablation System 2.2 by Gynesonics, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240503
Clearance Date2024-07-17
Clearance TypeTraditional
Product CodeKNF
Regulation Number884.4160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240503
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Sonata Transcervical Fibroid Ablation System 2.2 (K240503) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025 |
Trace the full predicate network for K240503
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.