Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009526575

FEI Number

3009526575

Entity Name

Cook Medical EUDC GmbH

City/State/Country

Baesweiler North Rhine-Westphalia, DE

Establishment Address

Robert Koch StraBe 2, Baesweiler North Rhine-Westphalia 52499, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

N/A

PMA Number

P200023

All Registered Proprietary Names

EchoTip ClearCore EUS Biopsy Needle Compass BDS® Biliary Stent Lunderquist Extra Stiff Wire Guide, DC Wire Guides EchoTip Ultra Endoscopic Ultrasound Needle EchoTip Ultra Endobronchial High Definition Ultrasound Needle EchoTip Procore HD Ultrasound Biopsy Needle EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Pentax Scopes EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Olypmus Scopes 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
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-06-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-03-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2009-11-05
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
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-01-13
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	2018-12-07
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
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2022-08-15
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2010-06-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-12-19
NIU	Stent, Superficial Femoral Artery, Drug-Eluting	Unknown	Class 3	N/A	2012-11-29
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2022-05-12
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2007-03-14
QIJ	Endoscopic Transhepatic Venous Access Needle	Gastroenterology, Urology	Class 2	876.1050	2019-11-28
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2024-12-12
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2022-01-31
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-03-14
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2019-03-22
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2009-02-13
NIO	Stent, Iliac	Unknown	Class 3	N/A	2009-02-13
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-05-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-03-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2019-03-22
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
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-12-18
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2016-12-23
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2015-12-22
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2020-11-02

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
3001845648	COOK IRELAND LTD	LIMERICK, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009526575. Last updated year: 2026. Please use registration number 3009526575 when referencing this establishment in official correspondence.