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.

32 devices
1–12 of 32
EchoTip AcuCore? EUS Biopsy Needle (ECHO-BX-19)
K241209 · FCG Biopsy Needle · Gastroenterology & Urology
Jul 2024 90d
Zimmon? Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen? Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin? Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen? Sof-Flex? Pancreatic Stent (GPSO-SF. GPSOS-SF)
K233079 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Jun 2024 262d
EchoTip? AcuCore? Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · FCG Biopsy Needle · Gastroenterology & Urology
May 2023 60d
Compass BDS Biliary Stent
K213946 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
May 2022 143d
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
K210476 · FCG Biopsy Needle · Gastroenterology & Urology
May 2021 90d
EchoTip Insight Portosystemic Pressure Gradient Measuring System
DEN180062 · QIJ Endoscopic Transhepatic Venous Access Needle · Gastroenterology & Urology
Nov 2019 366d
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Nov 2018 18d
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
K172057 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Mar 2018 246d
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
K172044 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Feb 2018 236d
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · FEG Tube, Double Lumen For Intestinal Decompression And/or Intubation · Gastroenterology & Urology
Aug 2017 60d
Nasal Pancreatic Drainage Set
K171623 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Jul 2017 59d
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
K163468 · MUM Stent, Metallic, Expandable, Duodenal · Gastroenterology & Urology
May 2017 143d
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