Cook Ireland Ltd.
Limerick, IE
COOK IRELAND LTD appears in FDA device records in Limerick, IE. FDA records list 34 510(k) clearances between and , 80 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 34 510(k) clearances for Cook Ireland Ltd. between 2005 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | KTI | Substantially Equivalent | |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | FCG | Substantially Equivalent | |
| 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) | FGE | Substantially Equivalent | |
| K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | FCG | Substantially Equivalent | |
| K213946 | Compass BDS Biliary Stent | FGE | Substantially Equivalent | |
| 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 Needle | FCG | Substantially Equivalent | |
| DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System | QIJ | Unknown | |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | FGE | Unknown | |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set | FGE | Substantially Equivalent | |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | FGE | Substantially Equivalent | |
| 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 S | FGE | Substantially Equivalent | |
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | FEG | Substantially Equivalent | |
| K171623 | Nasal Pancreatic Drainage Set | FGE | Substantially Equivalent | |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | MUM | Substantially Equivalent | |
| K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | FGE | Unknown | |
| K163018 | Zilver 635 Biliary Stent | FGE | Unknown | |
| K162717 | Evolution Esophageal Stent System – Partially Covered | ESW | Substantially Equivalent | |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | FCG | Substantially Equivalent | |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | FCG | Substantially Equivalent | |
| K122716 | PLASMATRODE SALINE SAFE TUR ELECTRODE | GEI | Substantially Equivalent | |
| K121430 | EVOLUTION BILIARY STENT SYSTEM | FGE | Unknown | |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | MQR | Substantially Equivalent | |
| K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | MUM | Substantially Equivalent | |
| K093619 | EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E | ESW | Substantially Equivalent | |
| K093195 | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O | FCG | Substantially Equivalent | |
| K092359 | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A | FCG | Substantially Equivalent | |
| K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM | ESW | Substantially Equivalent | |
| K063742 | RESONANCE METALLIC URETERAL STENT | FAD | Substantially Equivalent | |
| K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | FER | Substantially Equivalent | |
| K060624 | MARATHON STENT WITH FUSION TECHNOLOGY | FGE | Substantially Equivalent | |
| K052279 | COOK IRELAND ECHOBRUSH | FDX | Substantially Equivalent | |
| K050578 | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE | KNS | Substantially Equivalent | |
| K050294 | COOK IRELAND SONNET POLYPECTOMY SNARE | FDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001845648 | 3001845648 | COOK IRELAND LTD | O HALLORAN ROAD, LIMERICK Limerick(County) 000 IE | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FERAnoscope And Accessories
- FCGBiopsy Needle
- KTIBronchoscope Accessory
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- QIJEndoscopic Transhepatic Venous Access Needle
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- FHNLigator, Hemorrhoidal
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- ESWProsthesis, Esophageal
- FDISnare, Flexible
- MQRStent, Colonic, Metallic, Expandable
- NIOStent, Iliac
- QANStent, Iliac Vein
- MUMStent, Metallic, Expandable, Duodenal
- NIPStent, Superficial Femoral Artery
- NIUStent, Superficial Femoral Artery, Drug-Eluting
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2309-2012 | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment. | Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain