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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: ODG FDA class 2

    Endoscopic Ultrasound System, Gastroenterology-Urology

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Ultrasound System for Gastroenterology-Urology (product code ODG) is a diagnostic device combining endoscopy and ultrasound to provide ultrasonic visualization of body cavities accessible by endoscope, used in the GI and GU tracts for staging tumors, evaluating submucosal lesions, and guiding fine-needle aspiration. Reusable flexible endoscopes in this product code require validated reprocessing data in 510(k) submissions. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance. It carries no implant or life-sustaining flags.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Ultrasonic Gastrovideoscope
    EndoSound Vision System; EVS
    Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
    FUJIFILM Ultrasonic Endoscope EG-740UT
    Endoscope Model EG-580UT and Endoscope Model EG-580UR
    FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
    Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
    PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
    PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
    FUJIFILM Ultrasonic Endoscope
    PENTAX Medical Endoscopic Ultrasound System
    Ultramatrix EUS Balloon
    FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
    Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
    Endoscopic Ultrasound Aspiration Needle
    PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
    Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
    Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
    EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
    PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
    PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
    EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
    EXPECT ENDOSCOPIC ASPIRATION NEEDLE
    EG-3670URK
    EG-3870UTK
    EG-3670URK
    OLYMPUS BF TYPE UC160-OL8
    EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
    EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    FG-36UX FIBER ULTRASOUND GASTROSCOPE
    EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
    FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
    OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE
    OLYMPUS MH-246R BALLOON SHEATH
    PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
    ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
    PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA

    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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