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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: OCZ FDA class 2

    Endoscopic Grasping/Cutting Instrument, Non-Powered

    Gastroenterology, Urology

    View full classification →

    The Non-Powered Endoscopic Grasping/Cutting Instrument for Gastroenterology-Urology (product code OCZ) is a manually operated device used through an endoscope to grasp stones, tissues, or foreign objects, and to manipulate, sample, or cut tissues within the GI or GU tract during diagnostic or therapeutic procedures. These instruments include biopsy forceps, snares, and stone retrieval baskets. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
    Single Use Grasping Forceps
    Grasping Forceps
    Ensizor Endoscopic Scissors
    ENSIZOR ENDOSCOPIC SCISSORS
    ENDOSCOPIC SUTURE CUTTER
    ENDOSCOPIC RETRIEVAL DEVICE
    G-PROX EZ ENDOSCOPIC GRASPER
    ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
    MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
    HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
    XBO1-824-18/19/20 BIOPSY FORCEPS
    FLEXIBLE ENDOSCOPIC SCISSORS
    TELEMED SYSTEMS RETRIEVAL BASKET
    TRI TALON RETRIEVAL FORCEPS
    K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
    STONE EXTRACTOR
    COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
    T-RX RETRIEVAL FORCEPS
    PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    OLYMPUS BASKET GRASPERS (UROLOGY)
    OLYMPUS FG SERIES GRASPING FORCEPS
    OLYMPUS BASKET GRASPERS
    OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
    BLADE, SCALPEL & BLADE, HANDEL
    KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
    GIP/MEDI-GLOBE GOREIGN BODY GRASPERS
    BASICS ENDOSCOPY SYSTEM
    BIOPSY SCISSORS
    GRASPING FORCEPS FLEXIBLE STONE DISLODGER
    COX DISPOSABLE RETRIEVAL DEVICES
    BIOSPSY FORCEPS
    GRASPING FORCEPS
    CORPAK GRASPING FORCEPS
    WILSON-COOK RETRIEVAL & GRASPING FORCEPS
    PORGES BIOPSY & FOREIGN BODY FORCEPS
    WILTEK GRASPING FORCEPS
    3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
    DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
    3 FRENCH FLEXIBLE BIOPSY FORCEPS
    GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS
    HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
    RAT TOOTH GRASPING FORCEP (MODEL 23/20)
    OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO
    OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)
    GRASPING TRIPOD FORCEP (MODEL 23/25)
    OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)
    OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)
    HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12)
    OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)

    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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