# Urotec Systems Corp.

- Location (FDA's records): Pittsburgh, PA
- FDA decisions: 2 (1985–1986): 2 510(k) clearances
- Product codes: KOD (2)
- Predicates its devices cite: 0 (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 that cite its devices most
- Rusch, Inc.: 1 (https://510kreport.com/company/rusch)

## Its most-cited devices
- K851684: Urotec/Franklin Soft Simplastic Catheter (1985), cited by 1

## Recent decisions
- K854625: Urotec Closed Irrigatiion Syringe (Mar 4, 1986)
- K851684: Urotec/Franklin Soft Simplastic Catheter (Jul 2, 1985)

Source page: https://510kreport.com/company/urotec-systems