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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: GZF FDA class 2

    Stimulator, Peripheral Nerve, Implanted (Pain Relief)

    Neurology

    View full classification →

    The Implanted Peripheral Nerve Stimulator for Pain Relief is a surgically implanted neuromodulation device that delivers electrical impulses to peripheral nerves to manage chronic pain conditions that have not responded to other treatments. 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 GZF under regulation 21 CFR 882.5870 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    23 matches
    K Number
    Device Name
    TalisMann Neuromodulation System
    Nalu Neurostimulation System for Peripheral Nerve Stimulation
    Freedom Peripheral Nerve Stimulator (PNS) System
    Neuspera Nuity System
    StimRouter Neuromodulation System
    Neuspera Neurostimulation System (NNS)
    Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
    StimRouter Neuromodulation System
    StimRouter Neuromodulation System
    IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
    Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
    StimQ Peripheral Nerve Stimulator (PNS) System
    StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
    RENEW NEUROSTIMULATION SYSTEM
    MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
    PERIPHERAL NERVE STIMULATION
    MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
    TECOTHANE 55D
    MEDTRONIC MODEL 3990 PNS LEAD
    MODELS 3987 AND 3988 RESUME LEAD FOR PNS
    MODEL 3587A RESUME II LEAD
    MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER

    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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