Gynesonics, Inc.
Gynesonics, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 2, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | April 2, 2025 |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | July 17, 2024 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | December 21, 2023 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | November 8, 2022 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | June 17, 2021 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | May 4, 2020 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | August 15, 2018 |
| K061153 | GYNESONICS EC6 TRANSDUCER | October 27, 2006 |