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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OCY FDA class 2

    Endoscopic Guidewire, Gastroenterology-Urology

    Gastroenterology, Urology

    View full classification →

    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.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    EasyPass Guidewire
    Radifocus Glidewire Endoscopic Wire
    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
    NovaGold High Performance Guidewire
    Acrobat Calibrated Tip Wire Guide
    JAGWIRE HIGH PERFORMANCE GUIDWIRE
    Predicate III Guidewire
    MANDREL GUIDEWIRE
    NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
    ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
    OSTAVI HYDROPHILIC GUIDEWIRE
    XENX STONE MANAGEMENT DEVICE
    NEO ERCP GUIDEWIRE
    AXCESS SOFT TIP WIRE GUIDE
    XENX
    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
    COOK WIRE GUIDES
    TAXI ENDOSCOPIC GUIDEWIRE
    MANDREL GUIDEWIRES OR M-WIRE
    GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
    NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
    TECHDEVICE GUIDEWIRE
    FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
    WILSON-COOK USW CAP AND WIRE LOCK
    TRACER METRO SMART WIRE GUIDE
    ENDO-GLIDE GUIDEWIRE
    DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
    RADIUS NEXT GENERATION GUIDEWIRE
    FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
    CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
    BARD DIRECTOR GUIDEWIRE (000560)
    FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
    BARD TIGER GUIDEWIRE MODEL 000540
    AMPLATZ SUPER STIFF GUIDEWIRE
    MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
    OLYMPUS GUIDE WIRE
    FLEX FINDER GUIDEWIRE
    MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
    WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
    450CM GUIDE WIRE FOR G.I. USE
    SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
    MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
    GUIDE WIRE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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