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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: LKF FDA class 2

    Cannula, Manipulator/Injector, Uterine

    Obstetrics/Gynecology

    View full classification →

    Cannula, Manipulator/Injector, Uterine is a surgical instrument used in gynecological procedures, particularly laparoscopy, to manipulate the uterus into various positions and to inject fluids into the uterine cavity. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKF, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FemVue MINI Saline-Air Device
    RELIEEV Uterine Manipulator Injector (CUMI 5.0)
    FemChec Controlled Saline-Air Device (FCD-250)
    Rejoni Intrauterine Catheter
    ALLY II Uterine Positioning System™ (UPS)
    Uterine ElevatOR PRO with OccludOR Balloon
    DUMI ManipulatOR
    Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
    Cook Silicone Balloon HSG Catheter
    Margolin HSG Cannula, Goldstein Sonohysterography Catheter
    Uterine Manipulator
    Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
    Unicare System, Unicare Manipulator
    uVue HSG/SHG Catheter
    Ally Uterine Positioning System
    ManipulatOR PRO, ManipulatOR
    SonoFlow Sonohysterography and Sonohysterosalpingography Device
    Air Bubble Based Infuser (ABBI)
    VCARE
    MANIPULATOR; MANIPULATOR PRO
    ALLY UPS
    CLEARVIEW TOTAL
    KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
    VIKY UP
    THE ADVANCE CATHETER FOR HSG AND SIS
    BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
    FEMCHEC PRESSURE MANAGEMET DEVICE
    FEMVUE SALINE-AIR DEVICE
    PANPAC HSG CATHETER SET
    H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
    FEMVUE CORNUAL BALLOON CATHETER
    PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
    VCARE DX
    PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
    EZ HSG CATHETER.FOAMSEAL CATHETER
    FEMVUE(TM) CATHETER SYSTEM
    PROBE HOLDER SYSTEM
    VCARE RETRACTOR/ELEVATOR
    SALINE/ CONTRAST MEDIA INFUSION CATHETER
    WALLACE ARTIFICIAL INSEMINATION CATHETER
    INTRAUTERINE VENOGRAM NEEDLE SET
    SOFTSEAL HSG CATHETER
    HSG CATHETER SET
    H/S CATHETER SET
    INTRAUTERINE DELIVERY SYSTEM - INJECTOR
    UTERINE INJECTOR
    SIB CATHETER, MODEL 61-7005
    H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
    UTERINE INJECTOR
    H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007

    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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