FDA 510(k)

EZ-TRAX Containment Device

K-Number: K192487 · 2019-12-23

Decision Date2019-12-23

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EZ-TRAX Containment Device is a medical device manufactured by K1 Medical, LLC. It received FDA 510(k) clearance on 2019-12-23 under approval number K192487. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-TRAX Containment Device?

EZ-TRAX Containment Device is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by K1 Medical, LLC. The 510(k) number is K192487.

When was EZ-TRAX Containment Device approved by the FDA?

EZ-TRAX Containment Device received FDA 510(k) clearance on 2019-12-23, under approval number K192487.

What company makes EZ-TRAX Containment Device?

EZ-TRAX Containment Device is manufactured by K1 Medical, LLC.

What is the FDA product code for EZ-TRAX Containment Device?

The FDA product code for EZ-TRAX Containment Device is KCT.

Other Devices by K1 Medical, LLC

K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device K211007EZ-TRAXTM Persona Knee Containment Device

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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.