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Urotronic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250910Optilume® High Pressure Urological Balloon Dilation CatheterMay 22, 2025
K191061Optilume Basic Urological Balloon Dilation CatheterJanuary 2, 2020