Qitexio® 4-Way Stopcock (QIT014)— 510(k) K242255
Substantially EquivalentMedex
FDA 510(k) clearance K242255 for Qitexio® 4-Way Stopcock (QIT014), Substantially Equivalent on 2025-04-29. Applicant: Medex. Device class: 2.
Clearance details
- Applicant
- Medex
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint-Priest, FR
Recent devices under product code FMG
view all- K223499 — Three Way Stop Cock
- K223175 — lntravascular Administration Sets with Stopcock and Manifold
- K211204 — SafePort(TM) Manifold (or Stopcock)
- K210516 — Clicky Cross
- K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
More clearances from Medex
view allAdverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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.