Cook Ireland Ltd.
FDA Regulatory Profile
Cook Ireland Ltd. appears in FDA public data with 1 recall, 33 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2309-2012, Class II) was initiated on January 5, 2012. Its most recent 510(k) clearance was granted on July 29, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 33
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2309-2012 | Class II | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adju | January 5, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | July 29, 2024 |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic | June 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 Ult | May 20, 2021 |
| DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System | November 20, 2019 |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | November 16, 2018 |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, | July 6, 2018 |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guidi | March 9, 2018 |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra | February 27, 2018 |
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | August 1, 2017 |
| K171623 | Nasal Pancreatic Drainage Set | July 31, 2017 |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | May 4, 2017 |
| K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | February 7, 2017 |
| K163018 | Zilver 635 Biliary Stent | December 23, 2016 |
| K162717 | Evolution Esophageal Stent System Partially Covered | December 21, 2016 |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High De | March 21, 2016 |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | December 19, 2014 |
| K122716 | PLASMATRODE SALINE SAFE TUR ELECTRODE | April 17, 2013 |
| K121430 | EVOLUTION BILIARY STENT SYSTEM | March 1, 2013 |