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Optilume® High Pressure Urological Balloon Dilation Catheter
FDA 510(k)Class II (US FDA 510(k))
510(k) K250910
Identifiers
- 510(k) Number
- K250910 FDA 510(k)
- FDA Product Code
- EZN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5470 FDA 510(k)
- Regulation Number
- 876.5470 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Optilume® High Pressure Urological Balloon Dilation Catheter by Urotronic, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250910 | Class II | Active |
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Manufacturer
- Manufacturer
- Urotronic, Inc.
Sources (1)
- FDA 510(k) K250910 24 fields · synced Jun 18, 2026