K250462
- 510(k) number
- K250462
- Device name
- UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
- Applicant
- Univlabs Technologies Private Limited IN
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2025-08-11
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250462.pdf
Official FDA record: K250462
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.