Data / Medical devices / Ireland / Cook Ireland Ltd

Cook Ireland Ltd: FDA-registered device maker in LIMERICK Limerick(County), Ireland, 22 510(k) clearances and 3 PMA approvals

Name: Cook Ireland Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cook Ireland Ltd is registered with the FDA (registration 3001845648) in LIMERICK Limerick(County), Ireland. It lists 19 device types. The FDA files 22 510(k) clearances and 3 PMA approvals under its listings, the newest dated July 29, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001845648
Address: O Halloran Road National Technology Park, LIMERICK Limerick(County), Ireland, 000
Owner or operator: COOK IRELAND LTD (9052427)
Roles: Complaint file establishment, Manufacturer
First device listed: October 30, 2006
Registered through: 2026
Brand names listed: Colon Decompression Set, Compass BDS® Biliary Stent, EchoTip AcuCoreTM EUS Biopsy Needle, EchoTip ClearCore EUS Biopsy Needle, EchoTip Insight Portosystemic Pressure Gradient Measuring System, EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Olypmus Scopes, EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Pentax Scopes, EchoTip Procore HD Ultrasound Biopsy Needle and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Anoscope And Accessories	FER	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Biopsy Needle	FCG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscopic Transhepatic Venous Access Needle	QIJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Colonic, Metallic, Expandable	MQR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Metallic, Expandable, Duodenal	MUM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-Eluting	NIU	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 29, 2024	K241209	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
June 14, 2024	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	Cook Ireland, Ltd.	accessdata.fda.gov
May 30, 2023	K230909	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 9, 2022	K213946	Compass BDS Biliary Stent	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 20, 2021	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	Cook Ireland, Ltd.	accessdata.fda.gov
November 20, 2019	DEN180062	EchoTip Insight Portosystemic Pressure Gradient Measuring System	QIJ	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
November 16, 2018	K182980	Zilver 518 Biliary Stent, Zilver 635 Biliary Stent	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
July 6, 2018	K180868	Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set	FGE	Substantially Equivalent	Cook Ireland	accessdata.fda.gov
February 27, 2018	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	Cook Ireland, Ltd.	accessdata.fda.gov
August 1, 2017	K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	FEG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
July 31, 2017	K171623	Nasal Pancreatic Drainage Set	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 4, 2017	K163468	Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered	MUM	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
December 23, 2016	K163018	Zilver 635 Biliary Stent	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
December 21, 2016	K162717	Evolution Esophageal Stent System Partially Covered	ESW	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
March 1, 2013	K121430	EVOLUTION BILIARY STENT SYSTEM	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
June 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	ESW	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
November 2, 2009	K092359	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 8, 2007	K063742	RESONANCE METALLIC URETERAL STENT	FAD	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
September 6, 2006	K060623	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE	FER	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
April 22, 2005	K050578	COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE	KNS	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
May 27, 2003	K030618	WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE	BSP	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
October 17, 2002	K022595	WILSON-COOK CYSTOTOME	KNS	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 9, 2020	P200023	Zilver Vena Venous Self-Expanding Stent	QAN	9	April 14, 2026	accessdata.fda.gov
November 14, 2012	P100022	ZILVER PTX DRUG-ELUTING PERIPHERAL STENT	NIU	43	March 25, 2026	accessdata.fda.gov
June 26, 2006	P050017	ZILVER VASCULAR STENT	NIO	25	April 14, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 5, 2012	61451	Class II	Terminated	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 i	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 Zilv	accessdata.fda.gov

Compare with other makers

Updated April 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.