# Urogen Pharma, Ltd.

- Location (FDA's records): Ra’Anana, IL
- FDA decisions: 5 (2018–2021): 5 510(k) clearances
- Product codes: QBL (3), KOD (2)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 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
- Hospira, Inc.: 1 (https://510kreport.com/company/hospira)
- Pluromed, Inc.: 1 (https://510kreport.com/company/pluromed)

## Its most-cited devices
- K180345: Uroject12 Syringe Lever (2018), cited by 1
- K190987: Uroject12 Syringe Lever (2019), cited by 1
- K180354: UroGen Ureteral Catheter (2018), cited by 1

## Recent decisions
- K211032: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (Nov 19, 2021)
- K203321: Cystoject Syringe Lever (Dec 9, 2020)
- K190987: Uroject12 Syringe Lever (Dec 2, 2019)
- K180354: UroGen Ureteral Catheter (Oct 30, 2018)
- K180345: Uroject12 Syringe Lever (Oct 17, 2018)

Source page: https://510kreport.com/company/urogen-pharma