FDA applicant
Sejong Medical Co., Ltd.
FDA records 9 decisions for Sejong Medical Co., Ltd. (Paju-Si, KR) from 2017 to 2026: 9 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 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 Sejong Medical 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 2017.
Planning a device like Sejong Medical 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) ReportOther applicant names beginning “Sejong”
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