KNF
- Product code
- KNF
- Device name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 44
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250705 | 2025-04-02 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | |
| K240503 | 2024-07-17 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | |
| K233848 | 2023-12-21 | Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 (SO |
Official FDA classification page: KNF
Classification and pathway per current FDA publications. Data from openFDA (CC0).