K253842
- 510(k) number
- K253842
- Device name
- Vena MicroAngioscope System
- Applicant
- Vena Medical Holdings Corp CA
- Product code
- LYK — Angioscope
- Decision date
- 2026-01-28
- Date received
- 2025-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253842.pdf
Official FDA record: K253842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.