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Urotronic, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250910 Optilume® High Pressure Urological Balloon Dilation CatheterEZN2025-05-22 View
510(k) K191061 Optilume Basic Urological Balloon Dilation CatheterKOE2020-01-02 View
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