FDA 510(k) Applications Submitted by Cook Ireland Ltd.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K210476	02/19/2021	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	Cook Ireland Ltd.
K163468	12/12/2016	Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered	Cook Ireland Ltd.
K162717	09/29/2016	Evolution Esophageal Stent System û Partially Covered	Cook Ireland Ltd.
DEN180062	11/19/2018	EchoTip Insight Portosystemic Pressure Gradient Measuring System	Cook Ireland Ltd.
K230909	03/31/2023	EchoTip« AcuCoreÖ Ultrasound Biopsy Needle (ECHO-BX-3-22)	Cook Ireland Ltd.
K160229	02/01/2016	Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle	Cook Ireland Ltd.
K163018	10/31/2016	Zilver 635 Biliary Stent	Cook Ireland Ltd.
K172057	07/06/2017	Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set	Cook Ireland Ltd.