Product Code: OCY FDA class 2 21 CFR 876.1500

Endoscopic Guidewire, Gastroenterology-Urology

Gastroenterology, Urology

The Endoscopic Guidewire for Gastroenterology-Urology (product code OCY) is a flexible wire device used to provide access to the gastrointestinal or genitourinary tract for the purpose of passing or exchanging other endoscopic accessories during diagnostic and interventional procedures. Guidewires facilitate navigation through anatomical lumens and serve as a rail for catheter or device exchange. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, cleared through the De Novo pathway (submission type 4). It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OCY
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153264	EasyPass Guidewire	May 19, 2016	Substantially Equivalent	Medi-Globe Corporation
K151471	Radifocus Glidewire Endoscopic Wire	Sep 17, 2015	Substantially Equivalent	Terumo Medical Corporation
K150927	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	May 27, 2015	Substantially Equivalent	Coloplast A/S
K150225	NovaGold High Performance Guidewire	Mar 16, 2015	Substantially Equivalent	Neometrics, Inc.
K142950	Acrobat Calibrated Tip Wire Guide	Nov 05, 2014	Substantially Equivalent	Wilson-Cook Medical, Inc.
K141820	JAGWIRE HIGH PERFORMANCE GUIDWIRE	Oct 21, 2014	Substantially Equivalent	Boston Scientific Corp
K142397	Predicate III Guidewire	Sep 19, 2014	Substantially Equivalent	Lake Region Medical
K140482	MANDREL GUIDEWIRE	Apr 08, 2014	Substantially Equivalent	Lake Region Medical
K133076	NOVAGOLD HIGH PERFORMANCE GUIDEWIRE	Feb 20, 2014	Substantially Equivalent	Neometrics, Inc.
K131072	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC	Jul 09, 2013	Substantially Equivalent	Coloplast A/S
K124052	OSTAVI HYDROPHILIC GUIDEWIRE	Feb 26, 2013	Substantially Equivalent	Lake Region Medical
K123438	XENX STONE MANAGEMENT DEVICE	Jan 10, 2013	Substantially Equivalent	Xenolith Medical
K123439	NEO ERCP GUIDEWIRE	Jan 03, 2013	Substantially Equivalent	Neometrics, Inc.
K122816	AXCESS SOFT TIP WIRE GUIDE	Oct 09, 2012	Substantially Equivalent	Wilson-Cook Medical, Inc.
K113692	XENX	Aug 09, 2012	Substantially Equivalent	Xenolith Medical
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	May 22, 2009	Substantially Equivalent	Terumo Corp.
K082536	COOK WIRE GUIDES	Oct 27, 2008	Substantially Equivalent	Cook Urological, Inc.
K081708	TAXI ENDOSCOPIC GUIDEWIRE	Aug 26, 2008	Substantially Equivalent	Lake Region Mfg., Inc.
K080508	MANDREL GUIDEWIRES OR M-WIRE	Mar 21, 2008	Substantially Equivalent	Lake Region Medical
K072354	GUIDEWIRE, MODEL G-V220-3527S AND OTHERS	Dec 07, 2007	Substantially Equivalent	Accellent, Inc.
K060034	NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE	Feb 28, 2006	Substantially Equivalent	Nipro Medical Corporation
K053028	TECHDEVICE GUIDEWIRE	Jan 31, 2006	Substantially Equivalent	Techdevice Corporation
K050304	FX WIRE ADVANCED MEASUREMENT GUIDEWIRE	Mar 08, 2005	Substantially Equivalent	Conmedcorp
K040137	WILSON-COOK USW CAP AND WIRE LOCK	Feb 20, 2004	Substantially Equivalent	Wilson-Cook Medical, Inc.
K033754	TRACER METRO SMART WIRE GUIDE	Dec 30, 2003	Substantially Equivalent	Wilson-Cook Medical, Inc.
K023603	ENDO-GLIDE GUIDEWIRE	Feb 19, 2003	Substantially Equivalent	Endo-Therapeutics, Inc.
K021179	DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A	Jul 05, 2002	Substantially Equivalent	Olympus Optical Co., Ltd.
K011759	RADIUS NEXT GENERATION GUIDEWIRE	Aug 23, 2001	Substantially Equivalent	Radius Medical Technologies, Inc.
K990765	FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO	Mar 15, 1999	Substantially Equivalent	Flexmedics
K971937	CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE	Aug 15, 1997	Substantially Equivalent	Terumo Medical Corp.
K964780	BARD DIRECTOR GUIDEWIRE (000560)	Feb 26, 1997	Substantially Equivalent	C.R. Bard, Inc.
K964955	FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING	Feb 14, 1997	Substantially Equivalent	Flexmedics
K962178	BARD TIGER GUIDEWIRE MODEL 000540	Oct 29, 1996	Substantially Equivalent	C.R. Bard, Inc.
K944959	AMPLATZ SUPER STIFF GUIDEWIRE	Nov 04, 1994	Substantially Equivalent	Boston Scientific Corp
K943737	MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE	Aug 17, 1994	Substantially Equivalent	Boston Scientific Corp
K933110	OLYMPUS GUIDE WIRE	Nov 04, 1993	Substantially Equivalent	Olympus Corp.
K923755	FLEX FINDER GUIDEWIRE	Sep 03, 1993	Substantially Equivalent	Flex Medics Corporation
K931650	MICROVASIVE INSURG GEENEN CBD GUIDE WIRE	Jun 25, 1993	Substantially Equivalent	Boston Scientific Corp
K910497	WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE	Apr 02, 1991	Substantially Equivalent	Wilson-Cook Medical, Inc.
K910722	450CM GUIDE WIRE FOR G.I. USE	Mar 21, 1991	Substantially Equivalent	Terumo Corp.
K901429	SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE	Jun 05, 1990	Substantially Equivalent	Telemed Systems, Inc.
K892648	MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177	May 24, 1989	Substantially Equivalent	Boston Scientific Corp
K813026	GUIDE WIRE	Nov 17, 1981	Substantially Equivalent	Inmed Corp.