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FDA 510(k)

Tenax Laser Resistant Endotracheal Tube

K-Number: K200761 · 2020-11-25

ApplicantBryan Medical, Inc.
Decision Date2020-11-25
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Tenax Laser Resistant Endotracheal Tube is the device name listed in this FDA 510(k) record. The listed applicant is Bryan Medical, Inc.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) 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. The listed applicant is Bryan Medical, Inc.. The 510(k) number is K200761.

When did Tenax Laser Resistant Endotracheal Tube receive FDA 510(k) clearance?

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

Who is the listed applicant for Tenax Laser Resistant Endotracheal Tube?

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

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 records listing Bryan Medical, Inc. 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.

K213028Tenax Laser Resistant Endotracheal Tube

Related Devices (Code: BTR)

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.

K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe ApsK250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)Flexicare Medical Limited.

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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