FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Optilume® High Pressure Urological Balloon Dilation Catheter
K Number: K250910
·
Decision May 22, 2025
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
55
Applicant Total
1
Review Days
57
Basic Information
- Device Name
- Optilume® High Pressure Urological Balloon Dilation Catheter
- K Number
- K250910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5470
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Urotronic, Inc.
- Date Received
- March 26, 2025
- Decision Date
- May 22, 2025
- Product Code
- EZN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | FDA class 2 | Gastroenterology, Urology |
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