FDA applicant
Finemedix Co., Ltd.
FDA records 11 decisions for Finemedix Co., Ltd. (Daegu, KR) from 2018 to 2026: 11 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and PKL (Hemostatic Metal Clip For The Gi Tract). Since 2016 its 510(k)s took a median of 201 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 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 Finemedix Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Finemedix 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