# Urotronic, Inc.

- Location (FDA's records): Minneapolis
- FDA decisions: 4 (2020–2025): 2 510(k) clearances and 2 original PMA approvals
- Product codes: QRH (1), QXB (1), EZN (1), KOE (1)
- Predicates its devices cite: 2 (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)

## Recent decisions
- K250910: Optilume® High Pressure Urological Balloon Dilation Catheter (May 22, 2025)
- P220029: Optilume™ BPH Catheter System (Jun 30, 2023)
- P210020: Optilume Urethral Drug Coated Balloon (Dec 3, 2021)
- K191061: Optilume Basic Urological Balloon Dilation Catheter (Jan 2, 2020)

Source page: https://510kreport.com/company/urotronic