FDA applicant
Gni Co., Ltd.
FDA records 3 decisions for Gni Co., Ltd. (Hwaseong, KR) from 2019 to 2021: 3 510(k) clearances. Most are in product codes NJM (Bracket, Ceramic, Orthodontic) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gni Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Gni Co., 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