510(k) K251794

Tenax® Laser Resistant Endotracheal Tube by Bryan Medical, Inc. — Product Code BTR

K251794 is an FDA 510(k) premarket notification submitted by Bryan Medical, Inc. for the device "Tenax® Laser Resistant Endotracheal Tube". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Bryan Medical, Inc. has at least 3 other 510(k) clearances on record.