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 Boston Scientific Corp, Wilson-Cook Medical, Inc. and C.R. Bard, Inc..

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 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 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 Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
K131072
Coloplast A/S
Gastroenterology & Urology · 83d
Cleared Oct 09, 2012
AXCESS SOFT TIP WIRE GUIDE
K122816
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 25d
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 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 Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937
Terumo Medical Corp.
Gastroenterology & Urology · 80d
Cleared Feb 26, 1997
BARD DIRECTOR GUIDEWIRE (000560)
K964780
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Oct 29, 1996
BARD TIGER GUIDEWIRE MODEL 000540
K962178
C.R. Bard, Inc.
Gastroenterology & Urology · 145d
Cleared Nov 04, 1994
AMPLATZ SUPER STIFF GUIDEWIRE
K944959
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Aug 17, 1994
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K943737
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Nov 04, 1993
OLYMPUS GUIDE WIRE
K933110
Olympus Corp.
Gastroenterology & Urology · 132d
Cleared Jun 25, 1993
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Apr 02, 1991
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
K910497
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 56d
Cleared May 24, 1989
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648
Boston Scientific Corp
Gastroenterology & Urology · 42d

About Product Code OCY - Regulatory Context