Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cook Ireland, Ltd. — Predicate Candidate Screening

33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

262 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261274	EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for	Cook Ireland, Ltd.	2026-07-24	98	0
K241209	EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)	Cook Ireland, Ltd.	2024-07-29	90	0
K233079	Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, Z	Cook Ireland, Ltd.	2024-06-14	262	0
K230909	EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)	Cook Ireland, Ltd.	2023-05-30	60	0
K213946	Compass BDS Biliary Stent	Cook Ireland, Ltd.	2022-05-09	143	0
K210476	EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore	Cook Ireland, Ltd.	2021-05-20	90	1
DEN180062	EchoTip Insight Portosystemic Pressure Gradient Measuring Sy	Cook Ireland, Ltd.	2019-11-20	366	0
K182980	Zilver 518 Biliary Stent, Zilver 635 Biliary Stent	Cook Ireland, Ltd.	2018-11-16	18	0
K172057	Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stent	Cook Ireland, Ltd.	2018-03-09	246	0
K172044	Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-	Cook Ireland, Ltd.	2018-02-27	236	0
K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	Cook Ireland, Ltd.	2017-08-01	60	0
K171623	Nasal Pancreatic Drainage Set	Cook Ireland, Ltd.	2017-07-31	59	0
K163468	Evolution Duodenal Stent System - Uncovered, Evolution Colon	Cook Ireland, Ltd.	2017-05-04	143	0
K163169	Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent	Cook Ireland, Ltd.	2017-02-07	85	0
K163018	Zilver 635 Biliary Stent	Cook Ireland, Ltd.	2016-12-23	53	0
K162717	Evolution Esophageal Stent System – Partially Covered	Cook Ireland, Ltd.	2016-12-21	83	0
K160229	Echotip Ultra Endobronchial High Definition Ultrasound Needl	Cook Ireland, Ltd.	2016-03-21	49	0
K142688	Echotip Procore HD Ultrasound Biopsy Needle	Cook Ireland, Ltd.	2014-12-19	88	0
K122716	PLASMATRODE SALINE SAFE TUR ELECTRODE	Cook Ireland, Ltd.	2013-04-17	224	0
K121430	EVOLUTION BILIARY STENT SYSTEM	Cook Ireland, Ltd.	2013-03-01	291	0
K113510	EVOLUTION COLONIC STENT SYSTEM	Cook Ireland, Ltd.	2012-05-17	171	0
K113634	INJEKT CYSTO FLEXIBLE INJECTION NEEDLE	Cook Ireland, Ltd.	2012-02-14	67	0
K101530	EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22	Cook Ireland, Ltd.	2011-03-29	299	0
K093619	EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-2	Cook Ireland, Ltd.	2010-06-17	206	0
K093195	ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE	Cook Ireland, Ltd.	2010-01-21	104	0
K092359	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MOD	Cook Ireland, Ltd.	2009-11-02	90	1
K080359	EVOLUTION ESOPHAGEAL STENT SYSTEM	Cook Ireland, Ltd.	2008-05-09	88	0
K063742	RESONANCE METALLIC URETERAL STENT	Cook Ireland, Ltd.	2007-05-08	141	0
K060623	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW	Cook Ireland, Ltd.	2006-09-06	182	0
K060624	MARATHON STENT WITH FUSION TECHNOLOGY	Cook Ireland, Ltd.	2006-08-04	149	0
K052279	COOK IRELAND ECHOBRUSH	Cook Ireland, Ltd.	2005-10-11	50	0
K050578	COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE	Cook Ireland, Ltd.	2005-04-22	46	0
K050294	COOK IRELAND SONNET POLYPECTOMY SNARE	Cook Ireland, Ltd.	2005-03-31	52	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda