OCY · Class II · 21 CFR 876.1500

FDA Product Code OCY: Endoscopic Guidewire, Gastroenterology-urology

To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.

Leading manufacturers include Wilson-Cook Medical, Inc., Boston Scientific Corp and Lake Region Medical.

43
Total
43
Cleared
77d
Avg days
1981
Since

FDA 510(k) Cleared Endoscopic Guidewire, Gastroenterology-urology Devices (Product Code OCY)

43 devices
1–24 of 43
Cleared May 19, 2016
EasyPass Guidewire
K153264
Medi-Globe Corporation
Gastroenterology & Urology · 189d
Cleared Sep 17, 2015
Radifocus Glidewire Endoscopic Wire
K151471
Terumo Medical Corporation
Gastroenterology & Urology · 108d
Cleared May 27, 2015
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
K150927
Coloplast A/S
Gastroenterology & Urology · 51d
Cleared Mar 16, 2015
NovaGold High Performance Guidewire
K150225
Neometrics, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 05, 2014
Acrobat Calibrated Tip Wire Guide
K142950
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820
Boston Scientific Corp
Gastroenterology & Urology · 106d
Cleared Sep 19, 2014
Predicate III Guidewire
K142397
Lake Region Medical
Gastroenterology & Urology · 23d
Cleared Apr 08, 2014
MANDREL GUIDEWIRE
K140482
Lake Region Medical
Gastroenterology & Urology · 41d
Cleared Feb 20, 2014
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076
Neometrics, Inc.
Gastroenterology & Urology · 143d
Cleared Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
K131072
Coloplast A/S
Gastroenterology & Urology · 83d
Cleared Feb 26, 2013
OSTAVI HYDROPHILIC GUIDEWIRE
K124052
Lake Region Medical
Gastroenterology & Urology · 57d
Cleared Jan 10, 2013
XENX STONE MANAGEMENT DEVICE
K123438
Xenolith Medical
Gastroenterology & Urology · 63d
Cleared Jan 03, 2013
NEO ERCP GUIDEWIRE
K123439
Neometrics, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 09, 2012
AXCESS SOFT TIP WIRE GUIDE
K122816
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 09, 2012
XENX
K113692
Xenolith Medical
Gastroenterology & Urology · 238d
Cleared May 22, 2009
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
K091417
Terumo Corp.
Gastroenterology & Urology · 9d
Cleared Oct 27, 2008
COOK WIRE GUIDES
K082536
Cook Urological, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 26, 2008
TAXI ENDOSCOPIC GUIDEWIRE
K081708
Lake Region Mfg., Inc.
Gastroenterology & Urology · 70d
Cleared Mar 21, 2008
MANDREL GUIDEWIRES OR M-WIRE
K080508
Lake Region Medical
Gastroenterology & Urology · 25d
Cleared Feb 28, 2006
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
K060034
Nipro Medical Corporation
Gastroenterology & Urology · 54d
Cleared Mar 08, 2005
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304
Conmedcorp
Gastroenterology & Urology · 28d
Cleared Feb 20, 2004
WILSON-COOK USW CAP AND WIRE LOCK
K040137
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 30, 2003
TRACER METRO SMART WIRE GUIDE
K033754
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 05, 2002
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 81d

About Product Code OCY - Regulatory Context