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: HIH FDA class 2

    Hysteroscope (And Accessories)

    Obstetrics/Gynecology

    View full classification →

    The Hysteroscope (and accessories) is an endoscopic instrument introduced through the cervix into the uterine cavity to allow direct visualization of the endometrium and uterine structures, used for diagnostic evaluation and operative procedures such as polypectomy, myomectomy, or endometrial ablation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIH, regulated under 21 CFR 884.1690, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RZ Resectoscope System
    SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
    Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
    ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
    HTx Disposable Hysteroscope System
    SPY Cystoscope/Hysteroscope
    Endoscopic Video Image Processor, Single-Use Video Hysteroscope
    Benesta Tissue Removal Device
    HOPKINS Telescopes
    Aveta System 2.0
    UNIDRIVE SIII System
    Visera Hysterovideoscope Olympus HYF Type V
    Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
    Sheath, Stopcock Accessory
    Hystero-V Hysteroscope
    Medical Endoscope Image Processing System
    HTx Disposable Hysteroscope System
    BenestaTM Tissue Removal Device
    Schoelly Cystoscopes/Hysteroscopes and Accessories
    Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
    Benesta Hysteroscope
    Endosee System
    LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
    Resectr Tissue Resection Device
    Aveta Disposable Hysteroscope
    Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
    Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
    Aveta System
    Omni Hysteroscope, Omni Lok cervical seal
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
    MAKO 7
    Aveta System
    Endosee System
    Hysteroscope System
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Endosee System
    Polygon Resection Device
    Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
    TruClear Elite Hysteroscope
    MyoSure XL Tissue Removal Device for Fluent
    Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
    HSW Resection Instruments
    MyoSure MANUAL Tissue Removal Device
    GDT-1000 System
    LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
    Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
    Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
    Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
    Symphion Endoscope and Symphion Cervical Sheath

    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