Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gynetech Pty. , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | 2015-08-19 | 170 | 0 |
| K142700 | InsufflatOR Needle | Gynetech Pty. , Ltd. | 2014-12-19 | 88 | 0 |
| K142164 | MANIPULATOR; MANIPULATOR PRO | Gynetech Pty. , Ltd. | 2014-12-17 | 133 | 0 |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | 2005-09-02 | 78 | 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