FDA 510(k) Applications Submitted by Cook Ireland Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K241209 |
04/30/2024 |
EchoTip AcuCoreÖ EUS Biopsy Needle (ECHO-BX-19) |
Cook Ireland Ltd. |
| K233079 |
09/26/2023 |
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); Geen |
Cook Ireland Ltd. |
| K210476 |
02/19/2021 |
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 |
Cook Ireland Ltd. |
| K163468 |
12/12/2016 |
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered |
Cook Ireland Ltd. |
| K162717 |
09/29/2016 |
Evolution Esophageal Stent System û Partially Covered |
Cook Ireland Ltd. |
| DEN180062 |
11/19/2018 |
EchoTip Insight Portosystemic Pressure Gradient Measuring System |
Cook Ireland Ltd. |
| K230909 |
03/31/2023 |
EchoTip« AcuCoreÖ Ultrasound Biopsy Needle (ECHO-BX-3-22) |
Cook Ireland Ltd. |
| K160229 |
02/01/2016 |
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle |
Cook Ireland Ltd. |
| K163018 |
10/31/2016 |
Zilver 635 Biliary Stent |
Cook Ireland Ltd. |
| K172057 |
07/06/2017 |
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set |
Cook Ireland Ltd. |
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