510(k) K161813

Frova Intubating Introducer by William Cook Europe Aps — Product Code BTR

K161813 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "Frova Intubating Introducer". The FDA issued a decision of Substantially Equivalent on May 19, 2017. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. William Cook Europe Aps has at least 10 other 510(k) clearances on record.