FDA 510(k) Applications for Medical Device Product Code "OCY"
(Endoscopic Guidewire, Gastroenterology-Urology)

FDA 510(k) Number Applicant Device Name Decision Date
K072354 ACCELLENT INC. GUIDEWIRE, MODEL G-V220-3527S AND OTHERS 12/07/2007
K141820 BOSTON SCIENTIFIC CORP. JAGWIRE HIGH PERFORMANCE GUIDWIRE 10/21/2014
K964780 C.R. BARD, INC. BARD DIRECTOR GUIDEWIRE (000560) 02/26/1997
K962178 C.R. BARD, INC. BARD TIGER GUIDEWIRE MODEL 000540 10/29/1996
K131072 COLOPLAST A/S ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC 07/09/2013
K150927 COLOPLAST A/S Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff 05/27/2015
K050304 CONMED CORP. FX WIRE ADVANCED MEASUREMENT GUIDEWIRE 03/08/2005
K082536 COOK UROLOGICAL, INC. COOK WIRE GUIDES 10/27/2008
K023603 ENDO-THERAPEUTICS, INC. ENDO-GLIDE GUIDEWIRE 02/19/2003
K990765 FLEXMEDICS FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO 03/15/1999
K964955 FLEXMEDICS FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING 02/14/1997
K140482 LAKE REGION MEDICAL MANDREL GUIDEWIRE 04/08/2014
K080508 LAKE REGION MEDICAL MANDREL GUIDEWIRES OR M-WIRE 03/21/2008
K124052 LAKE REGION MEDICAL OSTAVI HYDROPHILIC GUIDEWIRE 02/26/2013
K142397 Lake Region Medical Predicate III Guidewire 09/19/2014
K081708 LAKE REGION MFG., INC. TAXI ENDOSCOPIC GUIDEWIRE 08/26/2008
K153264 MEDI-GLOBE CORPORATION EasyPass Guidewire 05/19/2016
K123439 NEOMETRICS, INC. NEO ERCP GUIDEWIRE 01/03/2013
K133076 NEOMETRICS, INC. NOVAGOLD HIGH PERFORMANCE GUIDEWIRE 02/20/2014
K150225 NEOMETRICS, INC. NovaGold High Performance Guidewire 03/16/2015
K060034 NIPRO MEDICAL CORPORATION NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE 02/28/2006
K021179 OLYMPUS OPTICAL CO., LTD. DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A 07/05/2002
K011759 RADIUS MEDICAL TECHNOLOGIES, INC. RADIUS NEXT GENERATION GUIDEWIRE 08/23/2001
K053028 TECHDEVICE CORPORATION TECHDEVICE GUIDEWIRE 01/31/2006
K091417 TERUMO CORP. SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A 05/22/2009
K971937 TERUMO MEDICAL CORP. CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE 08/15/1997
K151471 Terumo Medical Corporation Radifocus Glidewire Endoscopic Wire 09/17/2015
K122816 WILSON-COOK MEDICAL INC. AXCESS SOFT TIP WIRE GUIDE 10/09/2012
K142950 Wilson-Cook Medical, Inc Acrobat Calibrated Tip Wire Guide 11/05/2014
K033754 WILSON-COOK MEDICAL, INC. TRACER METRO SMART WIRE GUIDE 12/30/2003
K040137 WILSON-COOK MEDICAL, INC. WILSON-COOK USW CAP AND WIRE LOCK 02/20/2004
K113692 XENOLITH MEDICAL XENX 08/09/2012
K123438 XENOLITH MEDICAL XENX STONE MANAGEMENT DEVICE 01/10/2013


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