FDA applicant
Keyue (Hangzhou) Medical Information Technology Co., Ltd.
FDA records 1 decision for Keyue (Hangzhou) Medical Information Technology Co., Ltd. (Hangzhou, CN) in 2026: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Keyue (Hangzhou) Medical Information Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Keyue (Hangzhou) Medical Information…’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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