Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gynesonics, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
254 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025-04-02 | 23 | 0 |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024-07-17 | 147 | 0 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-22 | Gynesonics, Inc. | 2023-12-21 | 16 | 0 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022-11-08 | 99 | 0 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021-06-17 | 30 | 0 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation Sys | Gynesonics, Inc. | 2020-05-04 | 137 | 0 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation Syst | Gynesonics, Inc. | 2018-08-15 | 254 | 0 |
| K061153 | GYNESONICS EC6 TRANSDUCER | Gynesonics, Inc. | 2006-10-27 | 184 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda