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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: HET FDA class 2

    Laparoscope, Gynecologic (And Accessories)

    Obstetrics/Gynecology

    View full classification →

    The Gynecologic Laparoscope (and accessories) is an endoscopic instrument used for minimally invasive visualization of the pelvic organs, including the uterus, fallopian tubes, and ovaries, for diagnostic and surgical purposes. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HET, regulated under 21 CFR 884.1720, within the Obstetrics/Gynecology specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    i-Cut
    SIRIUS Endoscope System
    Video Endoscopy System, 3D Video Endoscopy System
    Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
    SurroundScope System
    TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
    4K UHD Camera System
    LAP-iX Suction Irrigation
    WV1 Endoscope
    ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
    Flex Robotic System and Flex Transabdominal Drive
    LAP-iX Suction Irrigation
    LAP-Pump PP110
    SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
    VISERA 4K UHD SYSTEM
    MORCELLEX SIGMA GENERATOR
    OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
    OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
    ENDOEYE HD II
    LINA XCISE MODEL MOR-1515
    TROKAMED MORCELLATOR
    GYNCARE MORCELLEX TISSUE MORCELLATOR
    MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
    ENDOSCOPIC CO2 REGULATION UNIT UCR
    STRYKER VIDEOSCOPE
    HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
    VERESS CANNULA AND MODULAR VERESS CANNULA
    APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
    G-LIX TISSUE GRASPER
    GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
    MILTEX LAPAROSCOPIC INSTRUMENTS
    VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
    APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
    POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
    COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
    XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
    REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
    VASOVIEW 5 HARVESTING CANNULA
    GYNECOLOGICAL LAPAROSCOPES
    BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
    MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
    TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
    MICRO-FRANCE TROCARS AND ACCESSORIES
    ENDOPATH SURESEAL REDUCER CAP
    CORTEK MINI LAPAROSCOPE
    THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
    CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
    GYNECARE LAPAROSCOPIC MORCELLATOR
    MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY

    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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