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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: HHK FDA class 2

    Curette, Suction, Endometrial (And Accessories)

    Obstetrics/Gynecology

    View full classification →

    The Endometrial Suction Curette (and accessories) is a device used to aspirate and collect endometrial tissue from the uterine lining for histopathological examination, typically performed as an outpatient procedure for the evaluation of abnormal uterine bleeding or endometrial pathology. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHK, regulated under 21 CFR 884.1175, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
    CrossGlide ETS Plus
    CrossBay Endometrial Tissue Sampler (ETS)
    DISPOSABLE ENDOMETRIAL SUCTION CURETTE
    THE PANPAC SUCTION CURETTE
    FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
    ENDOMETRIAL SAMPLING SYRINGE
    MAS WITH OR WITHOUT SYRINGE
    CURELLE, PREFERRED CURELLE, CUTEQ 2.5
    SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
    PIPET CURET
    FOWLER ENDOCURETTE, MODEL CUR-XXX
    APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
    GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
    RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
    ENDOMETRIAL SAMPLER
    SELECTCELLS(TM) MINI
    CPR D & C TRAY
    SELECTCELLS STANDARD
    MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
    CURELLE
    PIONEER PRO-PUMP
    PIONEER PRO-PUMP DUAL CONTROL
    PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
    CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
    ENDOMETRIAL SAMPLER
    MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
    ENDOMETRIAL PIPELLE
    VAKUTAGE
    MEDEVICES ASPIRATION HOSE
    U.V.A.C. HANDLER SET
    UTERINE ASPIRATION CURETTES(RIGID&FLEX)
    MENSTRUAL ASPIRATION KITS
    SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
    MASTERSON* ENDOMETRIAL BIOPSY KIT
    MONOJECT ENDOMETRIAL SAMPLING KIT
    BIOPSY KIT 781101, ASPIRATION
    ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
    ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
    CURETTE, UTERINE, VACUUM ASPIRATING
    CURETTE, PROPOSED TIS-U-TRAP, METAL

    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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