Qitexio® 4-Way Stopcock (QIT014)— 510(k) K242255

Substantially Equivalent

Medex

FDA 510(k) clearance K242255 for Qitexio® 4-Way Stopcock (QIT014), Substantially Equivalent on 2025-04-29. Applicant: Medex.

Clearance details

Applicant: Medex
Product code: Code FMG
Advisory panel: General Hospital
Date received: 2024-07-31
Decision date: 2025-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Priest, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.