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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 the device name listed in this FDA 510(k) record. The listed applicant is Medex. It received FDA 510(k) clearance on 2025-04-29 under 510(k) 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. The listed applicant is Medex. The 510(k) number is K242255.

When did Qitexio® 4-Way Stopcock (QIT014) receive FDA 510(k) clearance?

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

Who is the listed applicant for Qitexio® 4-Way Stopcock (QIT014)?

The FDA 510(k) record lists Medex as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medex as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203738Qitexio

Related Devices (Code: FMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223499Three Way Stop CockM/S Romsons InternationalK223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare CorporationK211204SafePort(TM) Manifold (or Stopcock)Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLCK190489Elcam Stopcocks and ManifoldsElcam Medical Acal

Official Source

View on FDA Database →

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

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