FDA applicant
Zhuhai Pusen Medical Technology Co., Ltd.
FDA records 7 decisions for Zhuhai Pusen Medical Technology Co., Ltd. (Zhuhai, CN) from 2017 to 2026: 7 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and FET (Endoscopic Video Imaging System/Component…). Since 2016 its 510(k)s took a median of 48 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 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 Zhuhai Pusen Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
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