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Cook Ireland, Ltd.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories9
Latest FDA decision2026-07-24
TypeNumberDevice NameCodeDateActions
510(k) K261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesKTI2026-07-24 View
PMA P050017 STENT, ILIACNIO2026-04-14 View
PMA P200023 Stent, iliac veinQAN2026-04-14 View
PMA P100022 Stent, superficial femoral artery, drug-elutingNIU2026-03-25 View
510(k) K241209 EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG2024-07-29 View
510(k) K233079 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)FGE2024-06-14 View
510(k) K230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG2023-05-30 View
510(k) K213946 Compass BDS Biliary StentFGE2022-05-09 View
510(k) K210476 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 NeedleFCG2021-05-20 View
510(k) K182980 Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE2018-11-16 View
510(k) K172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer SetFGE2018-03-09 View
510(k) K172044 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 SFGE2018-02-27 View
510(k) K171619 14Fr Colon Decompression Set, Macon Colon Decompression SetFEG2017-08-01 View
510(k) K171623 Nasal Pancreatic Drainage SetFGE2017-07-31 View
510(k) K163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM2017-05-04 View
510(k) K163169 Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentFGE2017-02-07 View
510(k) K163018 Zilver 635 Biliary StentFGE2016-12-23 View
510(k) K162717 Evolution Esophageal Stent System – Partially CoveredESW2016-12-21 View
510(k) K160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleFCG2016-03-21 View
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