About This 510(k) Submission
K210476 is an FDA 510(k) clearance for the EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 20, 2021, 90 days after receiving the submission on February 19, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.