Cook Ireland Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
33
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2309-2012Class IIZilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjuJanuary 5, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)July 29, 2024
K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic June 14, 2024
K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)May 30, 2023
K213946Compass BDS Biliary StentMay 9, 2022
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip UltMay 20, 2021
DEN180062EchoTip Insight Portosystemic Pressure Gradient Measuring SystemNovember 20, 2019
K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentNovember 16, 2018
K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set,July 6, 2018
K172057Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and GuidiMarch 9, 2018
K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra February 27, 2018
K17161914Fr Colon Decompression Set, Macon Colon Decompression SetAugust 1, 2017
K171623Nasal Pancreatic Drainage SetJuly 31, 2017
K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMay 4, 2017
K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentFebruary 7, 2017
K163018Zilver 635 Biliary StentDecember 23, 2016
K162717Evolution Esophageal Stent System – Partially CoveredDecember 21, 2016
K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High DeMarch 21, 2016
K142688Echotip Procore HD Ultrasound Biopsy NeedleDecember 19, 2014
K122716PLASMATRODE SALINE SAFE TUR ELECTRODEApril 17, 2013
K121430EVOLUTION BILIARY STENT SYSTEMMarch 1, 2013