BEUDAMED
    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: ODC FDA class 2

    Endoscope Channel Accessory

    Gastroenterology, Urology

    View full classification →

    The Endoscope Channel Accessory (product code ODC) is a gastroenterology and urology accessory designed to give the endoscope's working channel additional or improved functionality, such as modified flow characteristics, additional ports, or enhanced instrument passage capabilities. These accessories expand the utility of the endoscope for a variety of diagnostic and therapeutic applications. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Endoscopy Valve Set
    Luer-Split MAJ-2092
    Defendo Fujifilm 700 Single Use Cleaning Adapter
    Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
    DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
    Disposable Endoscope Valves Set (AF series)
    Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
    Endorail
    Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
    Defendo Single Use Cleaning Adapter for Olympus Endoscopes
    DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
    Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
    PENTAX Medical Gas/Water Feeding Valve OE-B14
    Disposable Endoscope Valves System
    Disposable Endoscope Valves Kit
    BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
    ANDORATE® Valve Kit
    Disposable Endoscope Valve Sets
    Pentax Medical Valve Set
    Disposable Endoscope Valves System
    Disposable Endoscopy Adapter Set
    FROG Forceps Valve (VAL1-F1-100)
    SnapLoc Wire Lock
    Guidewire Locking Device
    Wellead Endoscopic Seal
    andorate Suction Valve, andorate Air/Water Valve
    JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
    BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
    AutoCap RX
    BioGuard EUS Air/Water and Suction Valves
    BioGuard Air/Water and Suction Valves
    Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
    Locking device
    Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
    Andorate Biopsy Valve, Andorate Biopsy Irrigator
    Single Use Endoscope Valves Set
    Disposable Valve Sets
    Bio Guard Air/Water & Suction Valves
    Andorate Auxiliary Water Connector, Andorate Valves Set
    CleverLock Guidewire Locking Device and Biopsy Cap
    San Antonio Stopcock
    Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
    Accessory Irrigation Adapter
    SmartStart Air/Water and Suction Valves
    Disposable Endoscope Valves Set A
    BioGuard Air/Water Valve, BioGuard Suction Valve
    CONCENTRIC BALLOON GOOGLE
    NAVIAID ICVI-F,S,B,R DEVICE
    SUMO ACCESS AND TISSUE RESECTION SYSTEM
    NAVIAID(TM) BGC DEVICE

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump