FDA applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
FDA records 10 decisions for Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN) from 2023 to 2026: 10 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 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 Guangzhou Red Pine Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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