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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: HGI FDA class 2

    Electrocautery, Gynecologic (And Accessories)

    Obstetrics/Gynecology

    View full classification →

    The Gynecologic Electrocautery (and accessories) is a device that uses an electrically heated element to cauterize, coagulate, or destroy tissue in the female reproductive tract, used for procedures such as treatment of cervical erosion or minor lesions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGI, regulated under 21 CFR 884.4120, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IRIS Thermocoagulator and Digital Colposcope
    Liger Medical HTU-110
    FMWAND FERROMAGNETIC SURGICAL SYSTEM
    DOMAIN SURGICAL SYSTEM
    ENDOCERVICAL ELECTRODE # 2
    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
    THOMAS MEDICAL ELECTRODES
    SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
    TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
    LOOP ELECTRODE, BALL ELECTRODE
    DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
    GYNEX ELECTRODES
    ROCKET ELECTRODE
    VALLEY FORGE BIPOLAR LOOP
    TBD
    WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
    WALLACH INTEGRATION UNIT
    KSEA THERMOCOAGULATOR (MODEL 265100 20)
    KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
    LWEET CONE BIOPSY INSTRUMENT
    LOOP/SQUARE ELECTRODE
    ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
    LEEP SYSTEM 1000
    SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
    WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
    ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
    ELECTROSURGICAL LOOP ELECTRODE
    FINESSE IEC/601
    SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
    ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
    WALLACH LEEP PROCEDURE KIT
    ELECTROSURGICAL ELECTRODE
    MODEL 26-0375, ELECTROSURGICAL GENERATOR
    MODEL 80-1983, ELECTROSURGICAL GENERATOR
    LEEP AND LLETZ ELECTRODES
    SEDLACEK HANDLE
    CRYOMEDICS LLETZ LOOPS
    CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
    16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
    SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
    SURGISTAT
    FORCE 2
    FORCE 1C
    ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
    SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
    SINGLE USE LEE ELECTRODE
    SINGLE USE LEE ELECTRODE
    UTAH ESSU
    LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR

    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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