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FDA 510(k)

Dynarex Three-Way Stopcock

K-Number: K172266 · 2018-03-14

ApplicantDynarex Corporation
Decision Date2018-03-14
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Dynarex Three-Way Stopcock is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K172266. 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 Dynarex Three-Way Stopcock?

Dynarex Three-Way Stopcock is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Dynarex Corporation. The 510(k) number is K172266.

When did Dynarex Three-Way Stopcock receive FDA 510(k) clearance?

Dynarex Three-Way Stopcock received FDA 510(k) clearance on 2018-03-14, under 510(k) number K172266.

Who is the listed applicant for Dynarex Three-Way Stopcock?

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

What is the FDA product code for Dynarex Three-Way Stopcock?

The FDA product code for Dynarex Three-Way Stopcock is FMG.

Other records listing Dynarex Corporation 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.

K152970Dynarex Xeroform Petrolatum Dressing

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.

K242255Qitexio® 4-Way Stopcock (QIT014)MedexK223499Three 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, LLC

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.

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