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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: GXQ FDA class 2

    Dura Substitute

    Neurology

    View full classification →

    The Dura Substitute is an implanted neurosurgical material used to repair or replace the dura mater, the protective membrane surrounding the brain and spinal cord, following surgical procedures or traumatic injury. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is GXQ under regulation 21 CFR 882.5910 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    Helios Dura Regeneration Matrix
    ArtiFascia
    SyntheCel Dura Repair
    XenoSure Dura Biologic Patch
    Cerafix Dura Substitute
    DuraGen Secure Dural Regeneration Matrix
    Durepair Dura Regeneration Matrix
    Cerafix Dura Substitute
    Cerafix Dura Substitute
    Collagen Dural Regeneration Matrix
    DURAFORM Dural Graft Implant
    COLLAGEN DURA MEMBRANE
    BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
    SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
    BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
    LYOPLANT ONLAY
    DURAGEN SECURE DURAL REGNERATION MATRIX
    SYNTHECEL DURA REPLACEMENT DEVICES
    DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
    DURAGEN XS DURAL REGENERATION MATRIX
    LIFECELL DURAL SUBSTITUTE MATRIX
    MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
    DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
    DUREPAIR DURA REGENERATION MATRIX
    DURAGEN II DURAL REGENERATION MATRIX
    DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
    DUREPAIR DURA REGENERATION MATRIX
    CODMAN DURAFORM DURAL GRAFT IMPLANT
    DURAGEN PLUS DURAL GRAFT MATRIX
    DURASIS DURAL SUBSTITUTE
    PRECLUDE MVP DURA SUBSTITUTE
    SHELHIGH NO-REACT DURA SHIELD
    CODMAN ETHISORB DURA PATCH
    DURAGEN DURAL GRAFT MATRIX
    PRECLUDE ACUSEAL DURA SUBSTITUTE
    DURA-GUARD - DURAL REPAIR PATCH
    DURA-PATCH MODEL DP-XXX
    DURA-GUARD-DURAL REPAIR PATCH
    LYOPLANT DURA SUBSTITUTE(VARIOUS)
    NEURO-PATCH
    PRECLUDE DURA SUBSTITUTE
    DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

    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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