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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: FET FDA class 2

    Endoscopic Video Imaging System/Component, Gastroenterology-Urology

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Video Imaging System and its components are used to allow visualization of body cavities through an endoscope by projecting images to a monitor, enabling real-time viewing during gastrointestinal and urological endoscopic procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FET, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Endoscopic Camera System
    FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
    VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
    Endoscopic Video Image Processor (RP-IPD-V1000F)
    Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
    VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
    EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
    Logic Hd camera head green, System green
    Telepack +
    D Camera Controller
    Visera Elite II Video System Center
    Image1 S CCU, Image1 S 4U Camera Head
    Visera Elite II Video System Center
    Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
    FUJIFILM EP-6000 Video Processor
    Telepack +
    Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
    Pusen Eview Medical Video Endoscope Image Processor
    Telepack X LED
    LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
    EPX-4440FN Digital Video Processor with Light Source
    4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
    Processor VP-7000, Light Source BL-7000
    ENDOCAM Flex HD Camera System 5521
    Image1 SPIES System
    HD-Camera HDC1000
    EPX-4440HD and EPX-4400HD with FICE
    IMAGE1 SPIES
    THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
    PENTAX EPK-I5020 VIDEO PROCESSOR
    IMAGE1 GI CCU MODEL 22203020-114
    COLONOSCOPY ASSISTANT
    FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
    AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
    VS-100 ILLUMINATION AND IMAGING SYSTEM
    HD CAMERA HEAD OTV-S7PROH-HD-L08E
    IEC MEDSIGHT AND MEDBRIGHT
    ENDOSCOPY VIDEO CAMERA SYSTEM
    IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
    AIDA WITH DICOM AND HL7 INTERFACE
    OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
    KSEA OPSERVER LAP
    ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
    VP-1000; MED CAM 100; VP-3000A; MED CAM 300
    1-CCD ENDOCAM 5520 SYSTEM
    MODIFICATION TO VISTA STEREOSCOPE SYSTEM
    GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
    HILL-ROM PRIMAVIEW MONITOR SYSTEM
    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
    KSEA SCB-RUI SCO

    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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