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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: FFK FDA class 2

    Lithotriptor, Electro-Hydraulic

    Gastroenterology, Urology

    View full classification →

    The Electro-Hydraulic Lithotriptor is a device that generates a hydraulic shock wave via an electrical spark discharge to fragment stones in the urinary tract or biliary system. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFK, regulated under 21 CFR 876.4480, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
    Electrohydraulic Lithotriptor (TCS-B3-II)
    EL27-Compact; Sterile EHL-Probes
    URO-TOUCH 9 French Probe
    Swiss LithoClast Trilogy
    UreTron PF Series Probe
    UreTron MultiProbe Lithotripter System
    CYBERWAND STERILE PROBE SET
    AUTOLITH TOUCH; URO TOUCH
    SWISS LITHOBREAKER
    CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
    URETRON MODEL URT
    CYBERWAND LITHOTRIPTER
    VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
    CYBERWAND STERILE PADS, MODEL: CW-RBPBX
    LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
    CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
    SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
    CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
    EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
    INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
    MICROVASIVE LITHOTRIPTOR FLEXPROBE II
    KSEA CALCUSPLIT
    SWISS LITHOCLAST MULTIPURPOSE PROBE
    ELECTRO MECHANICAL LITHOTRIPTOR
    AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
    KSEA CALCUSPLIT
    LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
    MICROVASIVE LIPTHOTRIPSY PROBES
    SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
    EMS SWISS LITHOCLAST LITHOTRIPTER
    SWISS LITHOCLAST LITHOTRIPTER
    PULSE GUARD 3FR ELECTRODE
    RIWOLITH 2280 PROBES
    EHL PULSE GENERATOR
    EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
    PULSE GUARD ELECTRODE
    AUTOLITH-IEHL
    SD-200IEHL(TM)
    RIWOLITH 2280
    9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
    3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
    1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
    1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
    LITHOTRIPTOR SYSTEM MODEL 27080
    1.9 FRENCH LITHOTRIPTER ELECTRODE
    2.5 FRENCH LITHOTRIPTOR ELECTRODE
    TECHNOMED PULSOLITH LASER SYSTEM
    MDL-1 LASERTRIPTER(TM)
    TECHNOMED PULSOLITH LASER 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.

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