Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001845648

FEI Number

3001845648

Entity Name

COOK IRELAND LTD

City/State/Country

LIMERICK, IE

Establishment Address

O HALLORAN ROAD, NATIONAL TECHNOLOGY PARK, LIMERICK 000, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

COOK IRELAND LTD (Owner Number: 9052427)

Owner / Operator Contact Address

O'HALLORAN ROAD, NATIONAL TECHNOLOGY PARK, LIMERICK, IE-LK 00000, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230909

PMA Number

N/A

All Registered Proprietary Names

Nasal Pancreatic Drainage Set EchoTip ClearCore EUS Biopsy Needle Nagaraja Nasal Biliary Drainage Set Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Set Leung Nasal Biliary Drainage Set Compass BDS® Biliary Stent EchoTip Insight Portosystemic Pressure Gradient Measuring System EchoTip ClearCore EUS Biopsy Needle EchoTip AcuCoreTM EUS Biopsy Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-12-07
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2022-01-31
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-03-14
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2020-11-02
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2019-10-01
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-03-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-01-13
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2019-10-11
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2009-02-13
NIO	Stent, Iliac	Unknown	Class 3	N/A	2009-02-13
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-06-20
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-11-24
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2016-12-23
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2022-08-15
QIJ	Endoscopic Transhepatic Venous Access Needle	Gastroenterology, Urology	Class 2	876.1050	2019-11-28
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-14
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-03-14
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2010-06-21
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2006-10-30
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2006-10-30
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2017-05-10
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2017-05-10
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2007-03-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-05-17
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-09-27
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2023-09-27

Official Correspondent

Sinead Egan

US Agent Details

Matt Graf Business: Cook Medical Holdings LLC Email: Matt.Graf@CookMedical.com Phone: (812) 3392235

Related Public Records

Same Entity

COOK IRELAND LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009526575	Cook Medical EUDC GmbH	Baesweiler North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001845648. Last updated year: 2026. Please use registration number 3001845648 when referencing this establishment in official correspondence.