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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: NAY FDA class 2

    System, Surgical, Computer Controlled Instrument

    Gastroenterology, Urology

    View full classification →

    The Computer Controlled Surgical Instrument System is a robotic or computer-assisted surgical system used in urological, gastrointestinal, or other surgical procedures to enhance precision, dexterity, and control of surgical instruments through computer-mediated motion. If the device is reusable, validated reprocessing instructions must be included in the 510(k) submission. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.1500 (Gastroenterology and Urology specialty, reviewed by the General Surgery panel).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    da Vinci Firefly Imaging System
    Senhance Ultrasonic System
    da Vinci Force Feedback Instruments
    da Vinci Surgical System (IS5000)
    da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Surgical System (SP1098)
    da Vinci Surgical System (IS5000)
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Firefly Imaging System
    da Vinci Surgical System, IS5000
    Da Vinci Surgical System (IS5000)
    da Vinci Surgical System (IS5000)
    Vessel Sealer Curved (480522)
    da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
    SP Endoscope, 0° (430600)
    da Vinci SP Surgical System (SP1098)
    da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
    da Vinci SP Advanced Access Port Kit (432701)
    da Vinci Surgical System (IS5000)
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Instruments (SP1098)
    8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
    Senhance Surgical System
    da Vinci SP Surgical System (SP1098)
    da Vinci Surgical System (IS5000)
    da Vinci SP Surgical System (SP1098)
    da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
    da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
    da Vinci SP Surgical System
    da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
    Da Vinci SP Surgical System (SP1098)
    EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
    Senhance Surgical System
    da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
    da Vinci Firefly Imaging System
    da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
    Senhance Surgical System
    da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
    8mm Monopolar Curved Scissors
    8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
    da Vinci SP Firefly Imaging System
    Da Vinci SP Surgical System
    Senhance Surgical System
    da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
    Senhance Surgical System
    da Vinci SP Surgical System (SP1098)
    da Vinci SP Surgical System (SP1098)

    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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