FDA 510(k)

Qitexio® 4-Way Stopcock (QIT014)

K-Number: K242255 · 2025-04-29

ApplicantMedex

Decision Date2025-04-29

Product CodeFMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Qitexio® 4-Way Stopcock (QIT014) is a medical device manufactured by Medex. It received FDA 510(k) clearance on 2025-04-29 under approval number K242255. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qitexio® 4-Way Stopcock (QIT014)?

Qitexio® 4-Way Stopcock (QIT014) is a medical device that received FDA 510(k) clearance on 2025-04-29. It is manufactured by Medex. The 510(k) number is K242255.

When was Qitexio® 4-Way Stopcock (QIT014) approved by the FDA?

Qitexio® 4-Way Stopcock (QIT014) received FDA 510(k) clearance on 2025-04-29, under approval number K242255.

What company makes Qitexio® 4-Way Stopcock (QIT014)?

Qitexio® 4-Way Stopcock (QIT014) is manufactured by Medex.

What is the FDA product code for Qitexio® 4-Way Stopcock (QIT014)?

The FDA product code for Qitexio® 4-Way Stopcock (QIT014) is FMG.

Other Devices by Medex

K203738Qitexio

Related Devices (Code: FMG)

K172266Dynarex Three-Way StopcockDynarex Corporation K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC K190489Elcam Stopcocks and ManifoldsElcam Medical Acal K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal K210516Clicky CrossYomura Technologies, Inc. K223499Three Way Stop CockM/S Romsons International

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.