Gynesonics, Inc.
Redwood City, CA, US
GYNESONICS, INC. appears in FDA device records in Redwood City, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Gynesonics, Inc. between 2006 and 2025. The busiest year on record is 2006, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | KNF | Substantially Equivalent | |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | KNF | Substantially Equivalent | |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | KNF | Substantially Equivalent | |
| K061153 | GYNESONICS EC6 TRANSDUCER | ITX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005875675 | 3005875675 | GYNESONICS, INC. | 200 Cardinal Way #250, REDWOOD CITY, CA 94063 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain