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FDA 510(k)

Elcam Stopcocks and Manifolds

K-Number: K190489 · 2019-04-23

ApplicantElcam Medical Acal
Decision Date2019-04-23
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Elcam Stopcocks and Manifolds is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K190489. 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 Elcam Stopcocks and Manifolds?

Elcam Stopcocks and Manifolds is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Elcam Medical Acal. The 510(k) number is K190489.

When did Elcam Stopcocks and Manifolds receive FDA 510(k) clearance?

Elcam Stopcocks and Manifolds received FDA 510(k) clearance on 2019-04-23, under 510(k) number K190489.

Who is the listed applicant for Elcam Stopcocks and Manifolds?

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

What is the FDA product code for Elcam Stopcocks and Manifolds?

The FDA product code for Elcam Stopcocks and Manifolds is FMG.

Other records listing Elcam Medical Acal 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.

K231900A-TAP (previously called Arthrotap)K211204SafePort(TM) Manifold (or Stopcock)

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

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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