ProVee Video Processing Unit (PV-003)— 510(k) K251734
Substantially EquivalentProverum Limited
FDA 510(k) clearance K251734 for ProVee Video Processing Unit (PV-003), Substantially Equivalent on 2025-09-24. Applicant: Proverum Limited. Device class: 2.
Clearance details
- Applicant
- Proverum Limited
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin 1, IE
Recent devices under product code FET
view all- K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM01
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
- K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
- K250204 — Endoscopic Camera System
- K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.