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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: GZB FDA class 2

    Stimulator, Spinal-Cord, Implanted (Pain Relief)

    Neurology

    View full classification →

    The Implanted Spinal Cord Stimulator for Pain Relief is a surgically implanted neuromodulation device that delivers continuous or programmed electrical impulses to the spinal cord to reduce chronic pain conditions such as failed back surgery syndrome, complex regional pain syndrome, and neuropathic pain. 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 GZB under regulation 21 CFR 882.5880 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
    Nalu Neurostimulation System
    Nalu Neurostimulation System
    Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
    Nalu Neurostimulation SCS system
    SandShark Injectable Anchor (SIA) System
    Nalu Lead Blank (50cm)
    Freedom Spinal Cord Stimulator (SCS) System
    Nalu Neurostimulation System
    Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
    Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
    Freedom Spinal Cord Stimulator System
    A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
    Freedom Spinal Cord Stimulator System
    FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
    SWIFT-LOCK ANCHOR
    MULTI LEAD TRIAL CABLE
    MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
    RAPID PROGRAMMER
    FIXATE TISSUE BAND
    FIXATE TISSUE BAND
    OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
    FIXATE TISSUE BAND
    FIXATE TISSUE BAND
    MULTI-LEAD TRIALING CABLE MODEL 355531
    SWIFT-LOCK ANCHOR, MODEL 1192
    RAPID PROGRAMMER, VERSION 3.3.0
    PENTA LEAD KITS, MODELS: 3227-3234
    CINCH ANCHOR, MODEL 1194
    WIDE SPACED QUATTRODE LEADS
    TRIAL CABLE, 3009
    TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
    MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
    ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
    RAPID PROGEAMMER 3.0
    AXXESS BUTTERFLY ANCHOR
    MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
    ANS SCS ACCESSORY KIT
    TRIAL CABLE RETENTION CLIP
    RAPID PROGRAMMER
    POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
    MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
    LAMITRODE SPINAL CORD STIMULATION LEADS
    PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
    MODIFICATION TO RENEW LEAD EXTENSION
    ANS AXXESS PERCUTANEOUS LEAD
    PLACER
    RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR

    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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