FDA applicant
Woorhi Mechatronics Co., Ltd.
FDA records 1 decision for Woorhi Mechatronics Co., Ltd. (Gunpo-Si, KR) in 2026: 1 510(k) clearance. All are in product code QAI (Powered Microneedle Device). Its devices cite 1 predicate, 0 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 Woorhi Mechatronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Woorhi Mechatronics 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