FDA 510(k) Applications Submitted by Cook Ireland Ltd
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K182980 |
10/29/2018 |
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent |
Cook Ireland Ltd |
| K163169 |
11/14/2016 |
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent |
COOK IRELAND LTD |
| K050294 |
02/07/2005 |
COOK IRELAND SONNET POLYPECTOMY SNARE |
COOK IRELAND LTD |
| K050578 |
03/07/2005 |
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE |
COOK IRELAND LTD |
| K060623 |
03/08/2006 |
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
COOK IRELAND LTD |
| K060624 |
03/08/2006 |
MARATHON STENT WITH FUSION TECHNOLOGY |
COOK IRELAND LTD |
| K052279 |
08/22/2005 |
COOK IRELAND ECHOBRUSH |
COOK IRELAND LTD |
| K121430 |
05/14/2012 |
EVOLUTION BILIARY STENT SYSTEM |
COOK IRELAND LTD |
| K101530 |
06/03/2010 |
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D |
COOK IRELAND LTD |
| K093195 |
10/09/2009 |
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O |
COOK IRELAND LTD |
| K093619 |
11/23/2009 |
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E |
COOK IRELAND LTD |
| K113510 |
11/28/2011 |
EVOLUTION COLONIC STENT SYSTEM |
COOK IRELAND LTD |
| K213946 |
12/17/2021 |
Compass BDS Biliary Stent |
Cook Ireland LTD |
| K171619 |
06/02/2017 |
14Fr Colon Decompression Set, Macon Colon Decompression Set |
Cook Ireland Ltd |
| K172044 |
07/06/2017 |
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 |
Cook Ireland Ltd |
| K113634 |
12/09/2011 |
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
COOK IRELAND LTD |
| K122716 |
09/05/2012 |
PLASMATRODE SALINE SAFE TUR ELECTRODE |
COOK IRELAND LTD |
| K142688 |
09/22/2014 |
Echotip Procore HD Ultrasound Biopsy Needle |
COOK IRELAND LTD |
| K080359 |
02/11/2008 |
EVOLUTION ESOPHAGEAL STENT SYSTEM |
COOK IRELAND LTD |
| K171623 |
06/02/2017 |
Nasal Pancreatic Drainage Set |
Cook Ireland Ltd |
| K063742 |
12/18/2006 |
RESONANCE METALLIC URETERAL STENT |
COOK IRELAND LTD |
| K092359 |
08/04/2009 |
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A |
COOK IRELAND LTD |
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