LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)— 510(k) K240227

Substantially Equivalent

Lina Medical Aps

FDA 510(k) clearance K240227 for LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1), Substantially Equivalent on 2024-08-22. Applicant: Lina Medical Aps.

Clearance details

Applicant: Lina Medical Aps
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-01-26
Decision date: 2024-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glostrup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.