Medical Device Manufacturer · IE , Limerick

Cook Ireland, Ltd. - FDA 510(k) Cleared Devices

32 submissions · 27 cleared · Since 2005
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.

FDA 510(k) cleared devices by Cook Ireland, Ltd.

32 devices
1-12 of 32
Cleared Jul 29, 2024
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · FCG
Gastroenterology & Urology · 90d
Cleared Jun 14, 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
K233079 · FGE
Gastroenterology & Urology · 262d
Cleared May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · FCG
Gastroenterology & Urology · 60d
Cleared May 09, 2022
Compass BDS Biliary Stent
K213946 · FGE
Gastroenterology & Urology · 143d
Cleared May 20, 2021
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound...
K210476 · FCG
Gastroenterology & Urology · 90d
Not Cleared Nov 20, 2019
EchoTip Insight Portosystemic Pressure Gradient Measuring System
DEN180062 · QIJ
Gastroenterology & Urology · 366d
Cleared Nov 16, 2018
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · FGE
Gastroenterology & Urology · 18d
Cleared Mar 09, 2018
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets,...
K172057 · FGE
Gastroenterology & Urology · 246d
Cleared Feb 27, 2018
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex...
K172044 · FGE
Gastroenterology & Urology · 236d
Cleared Aug 01, 2017
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · FEG
Gastroenterology & Urology · 60d
Cleared Jul 31, 2017
Nasal Pancreatic Drainage Set
K171623 · FGE
Gastroenterology & Urology · 59d
Cleared May 04, 2017
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -...
K163468 · MUM
Gastroenterology & Urology · 143d
Filters