Company · IE
Cook Ireland, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 11 |
| FCG | Biopsy Needle | 7 |
| ESW | Prosthesis, Esophageal | 3 |
| MUM | Stent, Metallic, Expandable, Duodenal | 2 |
| FAD | Stent, Ureteral | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FDI | Snare, Flexible | 1 |
| FDX | Endoscopic Cytology Brush | 1 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 1 |
| FER | Anoscope And Accessories | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KTI | Bronchoscope Accessory | 1 |
| MQR | Stent, Colonic, Metallic, Expandable | 1 |
| NIO | Stent, Iliac | 1 |
| QIJ | Endoscopic Transhepatic Venous Access Needle | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasou Cook Ireland, Ltd., IE | KTI |
| Jul 29, 2024 | K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) Cook Ireland, Ltd., IE | FCG |
| Jun 14, 2024 | K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (G Cook Ireland, Ltd., IE | FGE |
| May 30, 2023 | K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) Cook Ireland, Ltd., IE | FCG |
| May 9, 2022 | K213946 | Compass BDS Biliary Stent Cook Ireland, Ltd., IE | FGE |
| May 20, 2021 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial Hig Cook Ireland, Ltd., IE | FCG |
| Nov 20, 2019 | DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland, Ltd., IE | QIJ |
| Nov 16, 2018 | K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent Cook Ireland, Ltd., IE | FGE |
| Jul 6, 2018 | K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Cook Ireland, IE | FGE |
| Mar 9, 2018 | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Cook Ireland, Ltd., IE | FGE |
| Feb 27, 2018 | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary S Cook Ireland, Ltd., IE | FGE |
| Aug 1, 2017 | K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set Cook Ireland, Ltd., IE | FEG |
| Jul 31, 2017 | K171623 | Nasal Pancreatic Drainage Set Cook Ireland, Ltd., IE | FGE |
| May 4, 2017 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered Cook Ireland, Ltd., IE | MUM |
| Feb 7, 2017 | K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent Cook Ireland, Ltd., IE | FGE |
| Dec 23, 2016 | K163018 | Zilver 635 Biliary Stent Cook Ireland, Ltd., IE | FGE |
| Dec 21, 2016 | K162717 | Evolution Esophageal Stent System Partially Covered Cook Ireland, Ltd., IE | ESW |
| Mar 21, 2016 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Cook Ireland, Ltd., IE | FCG |
| Dec 19, 2014 | K142688 | Echotip Procore HD Ultrasound Biopsy Needle Cook Ireland, Ltd., IE | FCG |
| Apr 17, 2013 | K122716 | PLASMATRODE SALINE SAFE TUR ELECTRODE Cook Ireland, Ltd., IE | GEI |
| Mar 1, 2013 | K121430 | EVOLUTION BILIARY STENT SYSTEM Cook Ireland, Ltd., IE | FGE |
| May 17, 2012 | K113510 | EVOLUTION COLONIC STENT SYSTEM Cook Ireland, Ltd., IE | MQR |
| Feb 14, 2012 | K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE Cook Ireland, Ltd., IE | FBK |
| Mar 29, 2011 | K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D Cook Ireland, Ltd., IE | MUM |
| Jun 17, 2010 | 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 Cook Ireland, Ltd., IE | ESW |
| Jan 21, 2010 | K093195 | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O Cook Ireland, Ltd., IE | FCG |
| Nov 2, 2009 | K092359 | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A Cook Ireland, Ltd., IE | FCG |
| May 9, 2008 | K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM Cook Ireland, Ltd., IE | ESW |
| May 8, 2007 | K063742 | RESONANCE METALLIC URETERAL STENT Cook Ireland, Ltd., IE | FAD |
| Sep 6, 2006 | K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE Cook Ireland, Ltd., IE | FER |
| Aug 4, 2006 | K060624 | MARATHON STENT WITH FUSION TECHNOLOGY Cook Ireland, Ltd., IE | FGE |
| Oct 11, 2005 | K052279 | COOK IRELAND ECHOBRUSH Cook Ireland, Ltd., IE | FDX |
| Apr 22, 2005 | K050578 | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE Cook Ireland, Ltd., IE | KNS |
| Mar 31, 2005 | K050294 | COOK IRELAND SONNET POLYPECTOMY SNARE Cook Ireland, Ltd., IE | FDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2012 | Cook Ireland Ltd. 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 ar Terminated |
NIO | None listed |