Urotronic, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Urotronic, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Optilume® High Pressure Urological Balloon Dilation Catheter, Optilume Basic Urological Balloon Dilation Catheter
2
Total
2
Cleared
0
Denied
Urotronic, Inc. has 2 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Latest FDA clearance: May 2025. Active since 2020. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Urotronic, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Libra Medical as regulatory consultant.
FDA 510(k) Regulatory Record - Urotronic, Inc.
2 devices