FDA.reportPublic FDA data

510(k) K133076

Device
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
Applicant
NEOMETRICS, INC.
510(k) number
K133076
Product code
OCY  
Decision
Substantially Equivalent (SESE)
Decision date
2014-02-20
Date received
2013-09-30
Regulation
876.1500
Classification name
Endoscopic Guidewire, Gastroenterology-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID LIEBL
Address
2605 Fernbrook Ln. N., Suite J Plymouth MN US 55447 55447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153264EasyPass GuidewireMedi-Globe Corporation2016-05-19
K151471Radifocus Glidewire Endoscopic WireTerumo Medical Corporation2015-09-17
K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffColoplast A/S2015-05-27
K150225NovaGold High Performance GuidewireNeometrics, Inc.2015-03-16
K142950Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc.2014-11-05
K141820JAGWIRE HIGH PERFORMANCE GUIDWIREBoston Scientific Corp2014-10-21
K142397Predicate III GuidewireLake Region Medical2014-09-19
K140482MANDREL GUIDEWIRELake Region Medical2014-04-08
K131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/S2013-07-09
K124052OSTAVI HYDROPHILIC GUIDEWIRELake Region Medical2013-02-26
K123438XENX STONE MANAGEMENT DEVICEXenolith Medical2013-01-10
K123439NEO ERCP GUIDEWIRENeometrics, Inc.2013-01-03
K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, Inc.2012-10-09
K113692XENXXenolith Medical2012-08-09
K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527ATerumo Corp.2009-05-22

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases