Panels › Gastroenterology, Urology › Product code OCY · Class 2
Endoscopic Guidewire, Gastroenterology-Urology
Regulation 876.1500
0510(k)s in 12 months (43 all time)
0recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in OCY
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Inc. | 0 | 9 |
| Boston Scientific Corp | 5 | 0 |
| Wilson-Cook Medical, Inc. | 5 | 0 |
| Lake Region Medical | 4 | 0 |
| Neometrics, Inc. | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Coloplast A/S | 2 | 0 |
| Flexmedics | 2 | 0 |
| Terumo Corp. | 2 | 0 |
| Terumo Medical Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2016 | K153264 | EasyPass Guidewire Medi-Globe Corporation | OCY |
| Sep 17, 2015 | K151471 | Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation | OCY |
| May 27, 2015 | K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic G Coloplast A/S | OCY |
| Mar 16, 2015 | K150225 | NovaGold High Performance Guidewire Neometrics, Inc. | OCY |
| Nov 5, 2014 | K142950 | Acrobat Calibrated Tip Wire Guide Wilson-Cook Medical, Inc. | OCY |
| Oct 21, 2014 | K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE Boston Scientific Corp | OCY |
| Sep 19, 2014 | K142397 | Predicate III Guidewire Lake Region Medical | OCY |
| Apr 8, 2014 | K140482 | MANDREL GUIDEWIRE Lake Region Medical | OCY |
| Feb 20, 2014 | K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE Neometrics, Inc. | OCY |
| Jul 9, 2013 | K131072 | ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC Coloplast A/S | OCY |
| Feb 26, 2013 | K124052 | OSTAVI HYDROPHILIC GUIDEWIRE Lake Region Medical | OCY |
| Jan 10, 2013 | K123438 | XENX STONE MANAGEMENT DEVICE Xenolith Medical, IL | OCY |
| Jan 3, 2013 | K123439 | NEO ERCP GUIDEWIRE Neometrics, Inc. | OCY |
| Oct 9, 2012 | K122816 | AXCESS SOFT TIP WIRE GUIDE Wilson-Cook Medical, Inc. | OCY |
| Aug 9, 2012 | K113692 | XENX Xenolith Medical, IL | OCY |
| May 22, 2009 | K091417 | 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 Terumo Corp. | OCY |
| Oct 27, 2008 | K082536 | COOK WIRE GUIDES Cook Urological, Inc. | OCY |
| Aug 26, 2008 | K081708 | TAXI ENDOSCOPIC GUIDEWIRE Lake Region Mfg., Inc. | OCY |
| Mar 21, 2008 | K080508 | MANDREL GUIDEWIRES OR M-WIRE Lake Region Medical | OCY |
| Dec 7, 2007 | K072354 | GUIDEWIRE, MODEL G-V220-3527S AND OTHERS Accellent, Inc. | OCY |
| Feb 28, 2006 | K060034 | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE Nipro Medical Corporation | OCY |
| Jan 31, 2006 | K053028 | TECHDEVICE GUIDEWIRE Techdevice Corporation | OCY |
| Mar 8, 2005 | K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE Conmedcorp | OCY |
| Feb 20, 2004 | K040137 | WILSON-COOK USW CAP AND WIRE LOCK Wilson-Cook Medical, Inc. | OCY |
| Dec 30, 2003 | K033754 | TRACER METRO SMART WIRE GUIDE Wilson-Cook Medical, Inc. | OCY |
| Feb 19, 2003 | K023603 | ENDO-GLIDE GUIDEWIRE Endo-Therapeutics, Inc. | OCY |
| Jul 5, 2002 | K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A Olympus Optical Co., Ltd. | OCY |
| Aug 23, 2001 | K011759 | RADIUS NEXT GENERATION GUIDEWIRE Radius Medical Technologies, Inc. | OCY |
| Mar 15, 1999 | K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO Flexmedics | OCY |
| Aug 15, 1997 | K971937 | CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE Terumo Medical Corp. | OCY |
| Feb 26, 1997 | K964780 | BARD DIRECTOR GUIDEWIRE (000560) C.R. Bard, Inc. | OCY |
| Feb 14, 1997 | K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING Flexmedics | OCY |
| Oct 29, 1996 | K962178 | BARD TIGER GUIDEWIRE MODEL 000540 C.R. Bard, Inc. | OCY |
| Nov 4, 1994 | K944959 | AMPLATZ SUPER STIFF GUIDEWIRE Boston Scientific Corp | OCY |
| Aug 17, 1994 | K943737 | MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE Boston Scientific Corp | OCY |
| Nov 4, 1993 | K933110 | OLYMPUS GUIDE WIRE Olympus Corp. | OCY |
| Sep 3, 1993 | K923755 | FLEX FINDER GUIDEWIRE Flex Medics Corporation | OCY |
| Jun 25, 1993 | K931650 | MICROVASIVE INSURG GEENEN CBD GUIDE WIRE Boston Scientific Corp | OCY |
| Apr 2, 1991 | K910497 | WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE Wilson-Cook Medical, Inc. | OCY |
| Mar 21, 1991 | K910722 | 450CM GUIDE WIRE FOR G.I. USE Terumo Corp. | OCY |
| Jun 5, 1990 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE Telemed Systems, Inc. | OCY |
| May 24, 1989 | K892648 | MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 Boston Scientific Corp | OCY |
| Nov 17, 1981 | K813026 | GUIDE WIRE Inmed Corp. | OCY |
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