# Leo Medical Co., Ltd.

- Location (FDA's records): Changzhou, CN
- FDA decisions: 2 (2018–2024): 2 510(k) clearances
- Product codes: FHN (1), FGE (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Recent decisions
- K241888: Single-use Balloon Dilatation Catheter (Dec 20, 2024)
- K172985: Ligation Device (Jun 14, 2018)

Source page: https://510kreport.com/company/leo-medical