FDA applicant
Intromedic Co., Ltd.
FDA records 11 decisions for Intromedic Co., Ltd. (Guro-Gu , Seoul, KR) from 2011 to 2026: 11 510(k) clearances. Most are in product codes NEZ (System, Imaging, Gastrointestinal, Wireless…) and EOX (Esophagoscope (Flexible Or Rigid)). Its devices cite 20 predicates, 12 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intromedic Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Intromedic Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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