Product code OCY— Gastroenterology, Urology
450CM GUIDE WIRE FOR G.I. USE
- Classification name
- Endoscopic Guidewire, Gastroenterology-Urology
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 43
- First cleared
- Most recent
FDA classification definition
“To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.”
Market context for product code OCY
FDA has cleared devices under product code OCY between 1981 and 2016, filed by 25 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2015
- 2014
- 2013
- 2012
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 1999
Top applicants under product code OCY
Adverse events under product code OCY
product code OCY- Injury
- 186
- Malfunction
- 578
- Total
- 764
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OCY
- K153264 — EasyPass Guidewire
- K151471 — Radifocus Glidewire Endoscopic Wire
- 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
- K150225 — NovaGold High Performance Guidewire
- K142950 — Acrobat Calibrated Tip Wire Guide
- K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE
- K142397 — Predicate III Guidewire
- K140482 — MANDREL GUIDEWIRE
- K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
- K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
- K124052 — OSTAVI HYDROPHILIC GUIDEWIRE
- K123438 — XENX STONE MANAGEMENT DEVICE
- K123439 — NEO ERCP GUIDEWIRE
- K122816 — AXCESS SOFT TIP WIRE GUIDE
- K113692 — XENX
- 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
- K082536 — COOK WIRE GUIDES
- K081708 — TAXI ENDOSCOPIC GUIDEWIRE
- K080508 — MANDREL GUIDEWIRES OR M-WIRE
- K072354 — GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
- K060034 — NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
- K053028 — TECHDEVICE GUIDEWIRE
- K050304 — FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
- K040137 — WILSON-COOK USW CAP AND WIRE LOCK
- K033754 — TRACER METRO SMART WIRE GUIDE
- K023603 — ENDO-GLIDE GUIDEWIRE
- K021179 — DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
- K011759 — RADIUS NEXT GENERATION GUIDEWIRE
- K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
- K971937 — CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
- K964780 — BARD DIRECTOR GUIDEWIRE (000560)
- K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
- K962178 — BARD TIGER GUIDEWIRE MODEL 000540
- K944959 — AMPLATZ SUPER STIFF GUIDEWIRE
- K943737 — MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
- K933110 — OLYMPUS GUIDE WIRE
- K923755 — FLEX FINDER GUIDEWIRE
- K931650 — MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
- K910497 — WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
- K910722 — 450CM GUIDE WIRE FOR G.I. USE
- K901429 — SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
- K892648 — MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
- K813026 — GUIDE WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.