Gynesonics, Inc.: FDA clearances and approvals
Gynesonics, Inc. has 8 FDA 510(k) clearances (first 2006, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time: 118 days. Since 2017 its median was 99 days, against 128 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 254 |
| 2019 | 0 | — |
| 2020 | 1 | 137 |
| 2021 | 1 | 30 |
| 2022 | 1 | 99 |
| 2023 | 1 | 16 |
| 2024 | 1 | 147 |
| 2025 | 1 | 23 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Gynesonics, Inc.'s cleared 510(k)s took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 7 | 7 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
Most recent Gynesonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2025-04-02 | 23 |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2024-07-17 | 147 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | KNF | 2023-12-21 | 16 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2022-11-08 | 99 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | KNF | 2021-06-17 | 30 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | KNF | 2020-05-04 | 137 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | KNF | 2018-08-15 | 254 |
| K061153 | GYNESONICS EC6 TRANSDUCER | ITX | 2006-10-27 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Gynesonics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Gynesonics, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02844920: Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (Completed, started 2017-07-20)
- NCT02228174: Sonography Guided Transcervical Ablation of Uterine Fibroids (Completed, started 2014-10)
Frequently asked questions
How many FDA 510(k) clearances does Gynesonics, Inc. have?
Gynesonics, Inc. has 8 FDA 510(k) clearances (first 2006, latest 2025), across 2 product codes in 2 review panels.
How long does FDA take to clear Gynesonics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gynesonics, Inc.'s cleared 510(k)s is 118 days. Since 2017: 99 days, versus 128 days for all cleared 510(k)s in the same product codes.
What devices does Gynesonics, Inc. make?
Its most frequent FDA product codes are KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), 7); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Has Gynesonics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gynesonics, Inc. Related entities may recall under other names.
Next steps
- See all 8 Gynesonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNF, Gynesonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.