This page includes the latest FDA filings for Gynesonics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3005875675 |
| FEI Number | 3005875675 |
| Name | GYNESONICS, INC. |
| Owner & Operator | Gynesonics |
| Contact Address | 600 Chesapeake Drive Redwood City CA 94063 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 600 Chesapeake Drive REDWOOD CITY, CA 94063 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
| Gynesonics, Inc. | Sonata® IUUS Probe Connector Protector ACCY-018 | 2025-05-26 |
| GYNESONICS, INC. | Sonata® IUUS Probe Leak Tester ACCY-017 | 2023-06-28 |
| GYNESONICS, INC. | Sonata® IUUS probe Leak Tester Kit ACCY-016 | 2023-06-28 |
| GYNESONICS, INC. | Sonata® Dispersive Electrode DE-001 | 2021-07-15 |
| GYNESONICS, INC. | Sonata® Radiofrequency Ablation Handpiece RFA-002 | 2021-07-15 |
| GYNESONICS, INC. | Sonata® RFA Handpiece Cable, Reusable ACCY-008 | 2021-07-15 |
Gynesonics, Inc. | Sonata Transcervical Fibroid Ablation System 2.2 | 2021-06-17 |
| GYNESONICS, INC. | Sonata® System Software SW-001 | 2021-05-19 |
| GYNESONICS, INC. | Sonata System Software SW-002 | 2020-10-15 |
| GYNESONICS, INC. | Sonata® Procedure Kit PROKIT-001 | 2020-10-15 |
| GYNESONICS, INC. | Sonata® Intrauterine Ultrasound Probe Return Kit RTN-001 | 2020-10-15 |
Gynesonics, Inc | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | 2020-05-04 |
| GYNESONICS, INC. | Sonata® Intrauterine Ultrasound Probe IUSP-002 | 2020-04-16 |
| GYNESONICS, INC. | Sonata® Intrauterine Ultrasound Probe IUSP-002S | 2020-04-16 |
| GYNESONICS, INC. | Sonata® IUUS Probe Sterile Shipper Kit SHPR-001 | 2019-11-08 |
| GYNESONICS, INC. | Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110 | 2019-05-20 |
| GYNESONICS, INC. | Sonata® System Radiofrequency Generator RFG2-110 | 2019-05-20 |
| GYNESONICS, INC. | Sonata® SMART Tablet USCON-2200 | 2019-05-20 |
| GYNESONICS, INC. | Sonata® System Cart ACCY-002 | 2019-05-20 |
| GYNESONICS, INC. | Sonata® IUUS Probe Soaking Cylinder CYL-001 | 2019-05-20 |
| GYNESONICS, INC. | Sonata® Case Kit CSKIT-001 | 2019-05-20 |
GYNESONICS, INC. [Gynesonics] | Sonata? Sonography-Guided Transcervical Fibroid Ablation System | 2018-09-18 |
GYNESONICS, INC. [Gynesonics] | Sonata? Sonography-Guided Transcervical Fibroid Ablation System | 2018-09-18 |
GYNESONICS, INC. [Gynesonics] | Sonata? Sonography-Guided Transcervical Fibroid Ablation System | 2018-09-18 |
Gynesonics, Inc. | Sonata Sonography-Guided Transcervical Fibroid Ablation System | 2018-08-15 |
GYNESONICS, INC. | GYNESONICS EC6 TRANSDUCER | 2006-10-27 |
| SEC | 0001341675 | GYNESONICS, INC of DELAWARE |