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OCY — Endoscopic Guidewire, Gastroenterology-Urology Class II

FDA Device Classification

Classification Details

Product Code
OCY
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153264medi-globe corporationEasyPass GuidewireMay 19, 2016
K151471terumo medical corporationRadifocus Glidewire Endoscopic WireSeptember 17, 2015
K150927coloplastOrchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic GuidewireMay 27, 2015
K150225neometricsNovaGold High Performance GuidewireMarch 16, 2015
K142950wilson-cook medicalAcrobat Calibrated Tip Wire GuideNovember 5, 2014
K141820boston scientificJAGWIRE HIGH PERFORMANCE GUIDWIREOctober 21, 2014
K142397lake region medicalPredicate III GuidewireSeptember 19, 2014
K140482lake region medicalMANDREL GUIDEWIREApril 8, 2014
K133076neometricsNOVAGOLD HIGH PERFORMANCE GUIDEWIREFebruary 20, 2014
K131072coloplastORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIREJuly 9, 2013
K124052lake region medicalOSTAVI HYDROPHILIC GUIDEWIREFebruary 26, 2013
K123438xenolith medicalXENX STONE MANAGEMENT DEVICEJanuary 10, 2013
K123439neometricsNEO ERCP GUIDEWIREJanuary 3, 2013
K122816wilson-cook medicalAXCESS SOFT TIP WIRE GUIDEOctober 9, 2012
K113692xenolith medicalXENXAugust 9, 2012
K091417terumoSINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A,May 22, 2009
K082536cook urologicalCOOK WIRE GUIDESOctober 27, 2008
K081708lake region mfgTAXI ENDOSCOPIC GUIDEWIREAugust 26, 2008
K080508lake region medicalMANDREL GUIDEWIRES OR M-WIREMarch 21, 2008
K072354accellentGUIDEWIRE, MODEL G-V220-3527S AND OTHERSDecember 7, 2007