FDA applicant
Kyung GI Medical Ind. Co., Ltd.
FDA records 1 decision for Kyung GI Medical Ind. Co., Ltd. (Kimpo-Si, Kyunggi-Do, KR) in 2002: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Kyung GI Medical Ind. Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kyung GI Medical Ind. Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kyung GI Medical Ind. 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 “Kyung”
FDA records each applicant name separately; these may or may not be the same firm.