FDA applicant
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
FDA records 7 decisions for Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (Guangzhou, CN) from 2025 to 2026: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FFK (Lithotriptor, Electro-Hydraulic). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
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