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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: GDY FDA class 1

    Gauze/Sponge, Internal, X-Ray Detectable

    General, Plastic Surgery

    View full classification →

    The Gauze/Sponge, Internal, X-Ray Detectable (product code GDY) is a surgical gauze or sponge used inside the body during procedures to absorb blood and fluids, featuring radiopaque material that makes it detectable by X-ray to prevent accidental retention within the patient after surgery. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4450 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ULTRACELL SUCTION SPONGE
    CPR LAP SPONGES
    STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
    PROTEC X-RAY DETECTABLE GAUZE SPONGE
    KENSORB
    ROUND STICK SPONGES, FLAT STICK SPONGES
    CHERRY DISSECTOR
    CHERRY PIT DISSECTOR
    TRIANGULAR SPONGES
    KITTNER DISSECTOR
    ROSEBUD DISSECTOR
    CYLINDRICAL SPONGE
    GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
    ULTRACELL ORTHOPEDIC SPONGES
    ULTRACELL ORTHOPEDIC SPONGES
    ULTRACELL ORTHOPEDIC SPONGES
    ULTRACELL RETRACTOR COVERS
    CHERRY DISSECTOR
    KITTNER DISSECTOR
    CYLINDRICAL SPONGE
    TRIANGULAR SPONGES
    ROUND STICK SPONGES, FLAT STICK SPONGES
    GAUZE SPONGES
    OREX (12X12 X-RAY DETECTABLE)
    OREX
    OREX (18X18 X-RAY DETECTABLE)
    PEANUT DISSECTOR
    ROSEBUD DISSECTOR
    CHERRY PIT DISSECTOR
    SPONGE, LAPAROTOMY, VARIOUS SIZE
    LORREX GAUZE SPONGES, X-RAY DETECTABLE
    STERILE X-RAY DETECTABLE GAUZE SPONGES
    LAP SPONGE PRODUCT LINE
    ISOLYSER (X-RAY DETECTABLE)
    ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
    ISOLYSER (4X18) X-RAY DETECTABLE
    ISOLYSER (18X18 X-RAY DETECTABLE)
    DUPAQUE SPONGE
    STERILE LAPAROTOMY SPONGES
    NEUROLOGICAL SPONGES
    SURGICAL SPONGE X-RAY DETECTABLE
    TONSIL SPONGES
    X-RAY PACKING SPONGE
    SPECIALTY SPONGES
    TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
    MEDLINE STERILE GAUZE SPONGES
    STERILE GAUZE SPONGES X-RAY DETECTABLE
    SPECIALTY SPONGES
    LAP SPONGES, MODIFIED
    SURGICAL SPONGES

    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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