FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
ProVee Video Processing Unit (PV-003)
K Number: K251734
·
Decision Sep 24, 2025
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
1
Review Days
110
Basic Information
- Device Name
- ProVee Video Processing Unit (PV-003)
- K Number
- K251734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Proverum Limited
- Date Received
- June 6, 2025
- Decision Date
- September 24, 2025
- Product Code
- FET
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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