FDA applicant
Zhejiang Geyi Medical Instrument Co., Ltd.
FDA records 2 decisions for Zhejiang Geyi Medical Instrument Co., Ltd. (Jiande City, CN) from 2025 to 2026: 2 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and HIH (Hysteroscope (And Accessories)). Its devices cite 2 predicates, 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 Zhejiang Geyi Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Zhejiang Geyi Medical Instrument Co.…’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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