Data / Medical devices / Ireland / Lake Region Medical Limited

Lake Region Medical Limited: FDA-registered device maker in NEW ROSS Wexford, Ireland, 3 510(k) clearances

Name: Lake Region Medical Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lake Region Medical Limited is registered with the FDA (registration 9681477) in NEW ROSS Wexford, Ireland. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 17, 2014. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 9681477
FEI number: 3002807439
Address: Butlersland, NEW ROSS Wexford, Ireland, --
Owner or operator: Lake Region Medical (2126666)
Roles: Contract manufacturer, Manufacturer
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: K080144, K770977, K850829, K935170, K935198, Predicate III, Steerant Super Stiff Guidewire

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter, G-U	KNY	2	Contract manufacturer	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Contract manufacturer	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Contract manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Contract manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Contract manufacturer	accessdata.fda.gov
Stylet For Catheter, Gastro-Urology	EZB	1	Contract manufacturer	accessdata.fda.gov
Stylet, Ureteral	EYA	1	Contract manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 17, 2014	K140536	HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
November 3, 2011	K112381	HI TORQUE CONNECT GUIDEWIRE	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
January 9, 2008	K073082	CPS COURIER GUIDEWIRE	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 17, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.