FDA 510(k)

Tenax Laser Resistant Endotracheal Tube

K-Number: K200761 · 2020-11-25

Decision Date2020-11-25

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Tenax Laser Resistant Endotracheal Tube is a medical device manufactured by Bryan Medical, Inc.. It received FDA 510(k) clearance on 2020-11-25 under approval number K200761. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenax Laser Resistant Endotracheal Tube?

Tenax Laser Resistant Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Bryan Medical, Inc.. The 510(k) number is K200761.

When was Tenax Laser Resistant Endotracheal Tube approved by the FDA?

Tenax Laser Resistant Endotracheal Tube received FDA 510(k) clearance on 2020-11-25, under approval number K200761.

What company makes Tenax Laser Resistant Endotracheal Tube?

Tenax Laser Resistant Endotracheal Tube is manufactured by Bryan Medical, Inc..

What is the FDA product code for Tenax Laser Resistant Endotracheal Tube?

The FDA product code for Tenax Laser Resistant Endotracheal Tube is BTR.

Other Devices by Bryan Medical, Inc.

K213028Tenax Laser Resistant Endotracheal Tube

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, 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.