Data / Medical devices / United States / Gynesonics, Inc.
Gynesonics, Inc.: FDA-registered device maker in Redwood City, CA, United States, 4 510(k) clearances
Gynesonics, Inc. is registered with the FDA (registration 3005875675) in Redwood City, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005875675
- Address
- 200 Cardinal Way #250, Redwood City, CA, United States, 94063
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Manufacturer
- First device listed
- July 25, 2025
- Registered through
- 2026
- Brand names listed
- Sonata Transcervical Fibroid Ablation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2025 | K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | Gynesonics, Inc. | accessdata.fda.gov |
| July 17, 2024 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | Gynesonics, Inc. | accessdata.fda.gov |
| November 8, 2022 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | Gynesonics, Inc. | accessdata.fda.gov |
| June 17, 2021 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | Substantially Equivalent | Gynesonics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated April 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.