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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: FAS FDA class 2

    Electrode, Electrosurgical, Active, Urological

    Gastroenterology, Urology

    View full classification →

    The Active Urological Electrosurgical Electrode (product code FAS) is a specialized electrode that serves as the active element of a urological electrosurgical system, delivering electrical energy to tissue during procedures such as transurethral resection. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Multi4 System
    PLASMA EDGE System
    Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
    Resection Electrodes with HF cable
    Electrosurgical accessory
    Resection Electrodes with HF cable
    Plasma Edge System
    Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
    Resection Electrodes
    GYRUS AMCI PK BUTTON ELECTRODE
    ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
    RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
    WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
    GYRUS ACMI PK BUTTON ELECTRODE
    MODERN MEDICAL RESECTOSCOPE ELECTRODES
    KSEA BIPOLAR ELECTROTOME
    MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
    ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
    OMNITECH FULGURATING ELECTRODE
    TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
    ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
    ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
    ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
    COAGULOOP
    USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
    ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    ELECTRODES/PROBES/DEVICES
    ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
    ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
    AMS COAGULOOP RESECTION ELECTRODE
    ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
    VAPOR-TECH SLED ELECTRODE
    RESECTOSCOPE CUTTING LOOP ELECTRODE
    OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    ENDOCARE MONOPOLAR ELECTRODE
    MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
    BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
    BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
    EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
    KSEA VAPORIZATION ELECTRODES
    ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
    VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
    ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
    SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
    ROLLER ELECTRODE
    POWER RESECTOSCOPE CUTTING LOOP
    ENDOSCOPIC ACCESSORY
    RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
    KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
    HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS

    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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