# Brightwater Medical

- Location (FDA's records): Dunlap, IL
- FDA decisions: 2 (2016–2019): 2 510(k) clearances
- Product codes: FGE (1), FAD (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: 3 (https://510kreport.com/company/boston-scientific)

## Recent decisions
- K181669: ConvertX Biliary Stent System (Mar 14, 2019)
- K161277: ConvertX Nephroureteral Stent System (Nov 22, 2016)

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