Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
FDA 510(k) K233848 · Gynesonics, Inc.
510(k) numberK233848
Submission
- Device name
- Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
- Applicant
- Gynesonics, Inc.
Redwood City, CA, US - Received
- December 5, 2023
- Decision date
- December 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KNF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | Gynesonics, Inc. | 04/02/2025SE |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | Gynesonics, Inc. | 07/17/2024SE |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | Gynesonics, Inc. | 11/08/2022SE |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | Gynesonics, Inc. | 06/17/2021SE |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1KNF · Traditional | Gynesonics, Inc. | 05/04/2020SE |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF · Traditional | Gynesonics, Inc. | 08/15/2018SE |
| K132135 | Lina Gold Loop HCKNF · Traditional | Lina Medical Aps | 01/31/2014SE |
| K121343 | Modulap LoopKNF · Traditional | Atc Technologies, Inc. | 06/14/2013SE |
| K103726 | Jarit Take-Apart Endoscopic InstrumentsKNF · Traditional | Integra LifeSciences Corporation | 02/08/2012SE |
| K092897 | Lap LoopKNF · Traditional | Medsys, S.A. | 02/01/2010SE |
More from Medsys, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | 04/02/2025SE |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | 07/17/2024SE |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | 11/08/2022SE |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | 06/17/2021SE |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1KNF · Traditional | 05/04/2020SE |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF · Traditional | 08/15/2018SE |
| K061153 | Gynesonics EC6 TransducerITX · Traditional | 10/27/2006SE |
Questions and answers
When was Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) cleared by the FDA?
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (K233848) received a 510(k) decision of Substantially Equivalent on December 21, 2023, 16 days after the submission was received.
What is the product code of K233848?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.