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: HEX FDA class 2

    Colposcope (And Colpomicroscope)

    Obstetrics/Gynecology

    View full classification →

    The Colposcope (and Colpomicroscope) is an illuminated magnifying instrument used to closely examine the cervix, vagina, and vulva for signs of disease, particularly in the evaluation of abnormal Pap smear results or visible lesions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEX, regulated under 21 CFR 884.1630, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Smart Scope® CX
    Gynescope System
    Biop Digital Colposcope
    Pocket Colposcope System
    LT-300 SD Digital Video Colposcope
    EVA (Enhanced Visual Assessment) System
    Colposcope System
    LT-300 HD
    Video Colposcope
    LT-300 Video Colposcope
    COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
    THE GYNOCULAR
    GC-3000E DIGITAL COLPOSCOPE
    AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
    ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
    DYSIS
    ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
    SEILER COLPOSCOPE, MODELS 935, 955 AND 985
    ECLERIS MICROSTAR COLPOSCOPE
    CERVICAL MD, MODEL C10
    COLPO-MASTER
    SOUNMED COLOPOSCOPE COLPO-99/99PLUS
    CO-1000 COLPOSCOPE, MULTIPLE
    IMAGE MANAGEMENT SYSTEM
    MEDISCOPE
    INTERMED ZOOM COLPOSCOPE
    GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
    DFV CPG COLPOSCOPE
    MEDSCOPE
    LEICA COLPOSCOPE
    TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
    LEISEGANG VIDEO COLPOSCOPE
    COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
    IMT LOUPE-COLPOSCOPE
    VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
    COLPOSCOPES AND ACCESSORIES
    HM-0690 COLPOSCOPE
    HM-0660
    ACCUSCOPE(TM) & ACCUSCOPE II(TM)
    LM-1Z ZOOM SCOPE
    ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002
    MALLEABLE PLACENTA CURETTE
    JEDMED KP6 COLPOSCOPE
    GYNESCOPE
    PHOTOSTAR V-8
    COLPOSTAR V-6
    WALLACH CONVERTIBLE COLPOSCOPE
    WALLACH ZOOM COLPOSCOPE
    OCS-2 COLPOSCOPE
    CERVISCOPE OPTICAL 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.

    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