# Sewoon Medical Co., Ltd.

- Location (FDA's records): Deer Field, IL
- FDA decisions: 1 (2002–2002): 1 510(k) clearance
- Product codes: EZL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (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
- Rochester Medical Corp.: 1 (https://510kreport.com/company/rochester-medical)

## Firms that cite its devices most
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)

## Its most-cited devices
- K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) (2002), cited by 1

## Recent decisions
- K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) (Feb 15, 2002)

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