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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: HIG FDA class 2

    Insufflator, Hysteroscopic

    Obstetrics/Gynecology

    View full classification →

    The Hysteroscopic Insufflator is a device used to distend the uterine cavity with gas (typically carbon dioxide) during hysteroscopic procedures, creating the space needed for visualization and operative access to the endometrial cavity. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIG, regulated under 21 CFR 884.1700, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
    X-FLO Fluid Management System
    Endomat Select, IBS Shaver Software, License
    Endomat Select
    Fluent Fluid Management System
    GYN-Pump PH304
    Aquilex Fluid Control System AQL-100S
    FluidSmart
    THERMEDX FLUID MANAGMENT SYSTEM
    HYSTEROSCOPY PUMP HM6
    AQUILEX FLUID CONTROL SYSTEM H112
    DOLPHIN 3 FLUID MANAGEMENT SYSTEM
    THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
    IUR FLUID MANAGEMENT SYSTEM
    AQUASENS FLUID MONITORING SYSTEM
    HYSTEREOSCOPY PUMP HM4
    DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
    AQUASENS FLUID MONITORING SYSTEM
    KARL STORZ HYSTEROMAT II
    DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
    HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
    HYS-SURGIFLATOR 150P
    HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
    AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
    HYSTERO CO2-PNEU 2221
    KARL STORZ MODEL 203020 20 EQUIMAT
    HYS-SURGIMAT
    HYS-SURGIFLATOR VP
    KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
    CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
    HYS-SURGIFLATOR
    THE KARL STORZ HAMOU ENDOMAT
    BARD HYSTERO-FLO II PUMP
    CONCEPT UNIVERSAL PUMP SYSTEM
    HYSTEROMAT(TM) 3700
    HYSTEROMED 100
    WOM HYSTEROFLATOR OP
    7-510-25 HYSTEROMED TUBING KIT
    INSUFFLATOR TUBING KIT
    THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
    HYSTEROFLATOR 1500
    LM-100/200LOW FLOW INSUFFLATOR
    HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
    GYN-1500 HYSTEROSCOPIC INUFFLATOR
    DAVOL SCOPE IRRIGATION SYSTEM
    CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
    REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
    HUI MINI-FLEX
    HYSTEROFLATOR 2001
    DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE

    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.

    Popular Product Codes

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