# Cook Ireland, Ltd.

- Location (FDA's records): Limerick, IE
- FDA decisions: 37 (2005–2026): 33 510(k) clearances, 1 De Novo grant and 3 original PMA approvals
- Names in FDA's records: Cook Ireland, Ltd. (36); Cook Ireland (1)
- Product codes: FGE (11), FCG (7), ESW (3), MUM (2), QAN (1), FER (1), KNS (1), MQR (1), FDX (1), FBK (1), FEG (1), FDI (1)
- 510(k) review time since 2016: median 90 days, against 100 for FDA's reviews in the same codes and years (4 of 12 faster)
- Predicates its devices cite: 70 (16 its own); citations of its devices by later devices: 32 (16 its own)
- Recalls linked to its devices: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wilson-Cook Medical, Inc.: 15 (https://510kreport.com/company/wilson-cook-medical)
- Cook, Inc.: 10 (https://510kreport.com/company/cook)
- Boston Scientific Corp: 9 (https://510kreport.com/company/boston-scientific)
- Cook Endoscopy: 4 (https://510kreport.com/company/cook-endoscopy)
- Cook Urological, Inc.: 3 (https://510kreport.com/company/cook-urological)
- Olympus Winter & Ibe GmbH: 2 (https://510kreport.com/company/olympus-winter-ibe)
- Don Wilson/Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/don-wilson-wilson-cook-medical)
- Canadian Theatre Products, Ltd.: 1 (https://510kreport.com/company/canadian-theatre-products)

## Firms that cite its devices most
- Boston Scientific Corp: 5 (https://510kreport.com/company/boston-scientific)
- Medi-Globe Corp.: 2 (https://510kreport.com/company/medi-globe)
- Changzhou Detain Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/changzhou-detain-medical-devices)
- Olympus Surgical Technologies America: 1 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Apollo Endosurgery, Inc.: 1 (https://510kreport.com/company/apollo-endosurgery)
- Conmed Endoscopic Technologies, Inc.: 1 (https://510kreport.com/company/conmed-endoscopic-technologies)
- Lina Medical Aps: 1 (https://510kreport.com/company/lina-medical)

## Its most-cited devices
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), cited by 4
- 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 (2018), cited by 3
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), cited by 3
- K142688: Echotip Procore HD Ultrasound Biopsy Needle (2014), cited by 3
- K101530: Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D (2011), cited by 2
- K050578: Cook Ireland Duette Multi-Band Mucosectomy Device (2005), cited by 2

## Recent decisions
- K261274: EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (Jul 24, 2026)
- K241209: EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (Jul 29, 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) (Jun 14, 2024)
- K230909: EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
- K213946: Compass BDS Biliary Stent (May 9, 2022)
- 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 (May 20, 2021)
- P200023: Zilver Vena Venous Self-Expanding Stent (Oct 9, 2020)
- DEN180062: EchoTip Insight Portosystemic Pressure Gradient Measuring System (Nov 20, 2019)

Source page: https://510kreport.com/company/cook-ireland