BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nalu Neurostimulation System for Peripheral Nerve Stimulation

    K Number: K232415 · Decision Aug 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    23
    Applicant Total
    9
    Review Days
    376

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    Basic Information

    Device Name
    Nalu Neurostimulation System for Peripheral Nerve Stimulation
    K Number
    K232415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Neuromodulation
    Date Received
    August 11, 2023
    Decision Date
    August 21, 2024
    Product Code
    GZF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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    Other Clearances by Boston Scientific Neuromodulation

    K Number Device Name
    K233801 Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
    K221376 Nalu Neurostimulation System
    K203547 Nalu Neurostimulation System
    K202274 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
    K201618 Nalu Neurostimulation SCS system
    K190960 Nalu Lead Blank (50cm)
    K183579 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
    K183047 Nalu Neurostimulation System