FDA 510(k)

Elcam Stopcocks and Manifolds

K-Number: K190489 · 2019-04-23

Decision Date2019-04-23

Product CodeFMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Elcam Stopcocks and Manifolds is a medical device manufactured by Elcam Medical Acal. It received FDA 510(k) clearance on 2019-04-23 under approval 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. It is manufactured by Elcam Medical Acal. The 510(k) number is K190489.

When was Elcam Stopcocks and Manifolds approved by the FDA?

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

What company makes Elcam Stopcocks and Manifolds?

Elcam Stopcocks and Manifolds is manufactured by Elcam Medical Acal.

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

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

Other Devices by Elcam Medical Acal

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

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 K211204SafePort(TM) Manifold (or Stopcock)Elcam Medical Acal K210516Clicky CrossYomura Technologies, Inc. K223499Three Way Stop CockM/S Romsons International K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation

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.