510(k) K953368

LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES by Karl Storz Endoskop GmbH — Product Code BTR

K953368 is an FDA 510(k) premarket notification submitted by Karl Storz Endoskop GmbH for the device "LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES". The FDA issued a decision of Substantially Equivalent on September 18, 1995. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Karl Storz Endoskop GmbH has at least 10 other 510(k) clearances on record.