Cook Ireland, Ltd. - FDA 510(k) Cleared Devices
32
Total
27
Cleared
1
Denied
FDA 510(k) cleared devices by Cook Ireland, Ltd. Gastroenterology & Urology ✕
31 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