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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: FBN FDA class 2

    Choledochoscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    View full classification →

    The Choledochoscope and Accessories (Flexible/Rigid) (product code FBN) is an endoscopic instrument used to examine and perform procedures within the bile ducts. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

    510(k) Clearances

    39 matches
    K Number
    Device Name
    Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
    Biliary Pancreaticobiliary Scope System
    Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
    Choledochoscope System
    Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
    Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
    Flexible Video-Choledochoscope System
    Single-use Video Pancreaticobiliary Scope, PB Digital Controller
    SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
    SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
    SpyGlass DS and DS II Direct Visualization System
    EndoCure Model EUR078A
    SpyGlass DS Direct Visualization System
    CHF-Y0005
    OLYMPUS CHF TYPE Y0003
    OLYMPUS CHF TYPE V
    XCHF-T160 VIDEOSCOPE
    OLYMPUS XCHF TYPE B180Y1
    ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
    OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
    MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
    KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
    FLEXIBLE MINI-FIBERSCOPES
    XCHF-33 CHOLEDOCHOFIBERSCOPE
    FCP-9P, FIBER CHOLEDOCHOSCOPE
    FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
    KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
    CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
    TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
    11274 AC FLEXINBLE CHOLEDOCHOSCOPE
    OMEGASCOPE
    DOSCOPE AND ACESSORIES
    CHOLEDOCHOSCOPE
    URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
    FLEXIBLE CHOLEDOCHOSCOPE
    CHF-B20 CHOLEDOCHOSCOPE
    FLEXIBLE CHOLEDOCHOSCOPE
    PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
    CHOLEDOCHOSCOPE SYSTEM

    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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