EZN
- Product code
- EZN
- Device name
- Dilator, Catheter, Ureteral
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5470
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 56 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250910 | 2025-05-22 | Urotronic, Inc. | Optilume® High Pressure Urological Balloon Dilation … |
Official FDA classification page: EZN
Classification and pathway per current FDA publications. Data from openFDA (CC0).