510(k) K160229

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle by Cook Ireland, Ltd. — Product Code FCG

K160229 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle". The FDA issued a decision of Substantially Equivalent on March 21, 2016. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.