FDA applicant
Gynetech Pty., Ltd.
FDA records 5 decisions for Gynetech Pty., Ltd. (Richmond, AU) from 1995 to 2015: 5 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and HHT (Spatula, Cervical, Cytological). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Gynetech, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gynetech Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gynetech Pty., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report