Cook Ireland, Ltd. - FDA 510(k) Cleared Devices
32
Total
27
Cleared
1
Denied
Cook Ireland, Ltd. has 27 FDA 510(k) cleared gastroenterology & urology devices. Based in Limerick, IE.
Latest FDA clearance: Jul 2024. Active since 2005.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Cook Medical as regulatory consultant.
32 devices
Cleared
Jul 29, 2024
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
Gastroenterology & Urology
90d
Cleared
Jun 14, 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
Gastroenterology & Urology
262d
Cleared
May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
Gastroenterology & Urology
60d
Cleared
May 09, 2022
Compass BDS Biliary Stent
Gastroenterology & Urology
143d
Cleared
May 20, 2021
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound...
Gastroenterology & Urology
90d
Not Cleared
Nov 20, 2019
EchoTip Insight Portosystemic Pressure Gradient Measuring System
Gastroenterology & Urology
366d
Cleared
Nov 16, 2018
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
Gastroenterology & Urology
18d
Cleared
Mar 09, 2018
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets,...
Gastroenterology & Urology
246d
Cleared
Feb 27, 2018
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex...
Gastroenterology & Urology
236d
Cleared
Aug 01, 2017
14Fr Colon Decompression Set, Macon Colon Decompression Set
Gastroenterology & Urology
60d
Cleared
Jul 31, 2017
Nasal Pancreatic Drainage Set
Gastroenterology & Urology
59d
Cleared
May 04, 2017
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -...
Gastroenterology & Urology
143d