Company · US
Gynesonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2025 | K250705 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Jul 17, 2024 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Dec 21, 2023 | K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) Gynesonics, Inc. | KNF |
| Nov 8, 2022 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Jun 17, 2021 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| May 4, 2020 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 Gynesonics, Inc. | KNF |
| Aug 15, 2018 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. | KNF |
| Oct 27, 2006 | K061153 | GYNESONICS EC6 TRANSDUCER Gynesonics, Inc. | ITX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||