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

    Nalu Neurostimulation System

    K Number: K183047 · Decision Mar 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    9
    Review Days
    140

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    Basic Information

    Device Name
    Nalu Neurostimulation System
    K Number
    K183047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Neuromodulation
    Date Received
    November 2, 2018
    Decision Date
    March 22, 2019
    Product Code
    GZB
    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
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GZB), ordered by most recent decision date.

    Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

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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
    K232415 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