Sonata Transcervical Fibroid Ablation System 2.2 — Gynesonics, Inc. (510(k) K222304)
Sonata Transcervical Fibroid Ablation System 2.2 — Gynesonics, Inc. (510(k) K222304) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Sonata Transcervical Fibroid Ablation System 2.2; Applicant: Gynesonics, Inc.; Clearance track: 510(k).
| Device name | Sonata Transcervical Fibroid Ablation System 2.2 |
|---|---|
| Applicant | Gynesonics, Inc. |
| Clearance track | 510(k) |
| Submission number | K222304 |
| Decision | Substantially Equivalent |
| Decision date | 2022-11-08 |
| Date received | 2022-08-01 |
| Product code | KNF |
| Device class | 2 |
| Medical specialty | Obstetrics/Gynecology |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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