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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: MGQ FDA unclassified

    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

    Unknown

    View full classification →

    The hydrogel wound and burn dressing with drug and/or biologic agent carries an unclassified (Class U) FDA designation, meaning its classification has not been formally determined. It combines a hydrogel matrix with an incorporated drug or biologic component to provide moisture management and therapeutic effects in wound and burn management. The product code is MGQ and no regulation number or formal medical specialty has been assigned. It is not implanted and does not sustain life.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HylaGuard Moisturizing Cream
    HYLATOPIC EMOLLIENT FOAM
    IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
    SILVERSITE OR CALGITROL
    SILVERSEAL
    TENDERWET ACTIVE
    MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
    SINCLAIR WOUND AND SKIN EMULSION
    XYLOS XCELL ANTIMICROBIAL DRESSING
    CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
    COLLATEK HYDROGEL
    REGENECARE WOUND GEL
    CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
    L.A.M. IPM WOUND GEL
    ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
    AMBU GEL, HYDROGEL BURN DRESSING
    DIAMOND ALOE VERA, STERILE
    BURN JEL PLUS
    GLUCANPRO CREAM
    BETA GLUCAN GEL (MACROPRO GEL)
    FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
    GLUCANPRO
    MACROPRO GEL
    MEDLINE TENDER WET WOUND DRESSING
    MPM REGENECARE WOUND GEL
    STERILE HYDROGEL
    BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
    BURNFREE PAIN RELIEVING GEL, MODEL 4B
    BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
    GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
    MODIFICATION TO WOUN'DRES
    DUODERM HYDROACTIVE GEL WOUND DRESSING
    HYPERGEL 20% HYPERTONIC SALINE GEL
    NORMLGEL 0.9% ISOTONIC SALINE GEL
    MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
    MODIFICATION OF BIONECT HYDROGEL SPRAY
    MODIFICATION OF BIONECT HYDROGEL FOAM
    BIONECT HYDROGEL
    MODIFICATION OF BIONECT CLEAR HYDROGEL
    BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
    NU-GEL * WOUND DRESSING
    SPYROGEL HYDROGEL WOUND AND BURN DRESSING
    SWEEN WOUN'DRES
    BRENNEN MEDICAL BETA GLUCAN GEL
    NEUFINISH RESURFACING CREAM
    POLYTUBE
    BIONECT HYDROGEL GAUZE PADS
    BIONECT CLEAR HYDROGEL
    BIONECT HYDROGEL FOAM
    BIONECT HYDROGEL SPRAY

    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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