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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: JXI FDA class 2

    Cuff, Nerve

    Neurology

    View full classification →

    Cuff, Nerve is a surgically implanted device placed around a peripheral nerve to deliver electrical stimulation or record neural signals for therapeutic or diagnostic purposes, with applications in pain management, neurological monitoring, and neuroprosthetics. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXI, regulated under 21 CFR 882.5275, and falls within the Neurology medical specialty. This device is an implant.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    SILKBridge
    NeuroSpan Bridge
    VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
    VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
    Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
    Nerve Wrap (07-DW-001-TAB)
    Mochida Nerve Cuff
    NerveTape
    Rebuilder Nerve Guidance Conduit
    VersaWrap Nerve Protector
    Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
    Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
    Nerve Tape
    NervAlign Nerve Cuff
    VersaWrap Nerve Protector
    NeuroShield
    Reaxon Plus
    AxoGen Nerve Cap
    Reinforced Flexible Collagen Nerve Cuff
    NeuraGen 3D Nerve Guide Matrix
    AxoGuard Nerve Connector
    NERBRIDGE
    Nerve Capping Device
    Reaxon Plus
    NEURAGEN 3D
    FLEXIBLE COOAGEN NERVE CUFF
    NERVE CUFF
    COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
    NEUROLAC(R) NERVE GUIDE
    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
    COLLAGEN NERVE WRAP
    NEUROLAC NERVE GUIDE
    NEURA WRAP NERVE PROTECTOR
    NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
    SURGISIS NERVE CUFF
    COLLAGEN NERVE CUFF
    NEUROGEN NERVE GUIDE
    SALUMEDICA NERVE CUFF
    NEUROTUBE
    FASTUBE NERVE REGENERATION DEVICE

    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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