FDA 510(k)

Tenax® Laser Resistant Endotracheal Tube

N.º K: K251794 · 2026-09-03

Fecha de decisión2026-09-03

Código de productoBTR

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2026-09-03 under 510(k) number K251794. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tenax® Laser Resistant Endotracheal Tube?

Tenax® Laser Resistant Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Bryan Medical, Inc.. The 510(k) number is K251794.

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

Tenax® Laser Resistant Endotracheal Tube received FDA 510(k) clearance on 2026-09-03, under 510(k) number K251794.

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.

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Otros registros que enlistan a Bryan Medical, Inc. como solicitante

K213028Tenax Laser Resistant Endotracheal Tube K200761Tenax Laser Resistant Endotracheal Tube

Dispositivos relacionados (Código: BTR)

K253437Spiro-VISTASpiro Robotics K250173Shiley™ 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, LLC K243785Shiley™ 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, LLC K243579Catheter de Ventilación AeroJetPipeline Medical Products, LLC K251499Frova 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 Aps K250243ProVu 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.

Fuente oficial

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