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510(k) Data Aggregation

    K Number
    K223306
    Device Name
    SPRINT Peripheral Nerve Stimulation (PNS) System
    Manufacturer
    SPR Therapeutics, Inc.
    Date Cleared
    2023-01-25

    (90 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for: - Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - Symptomatic relief of post-traumatic pain; - Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
    Device Description
    The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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    K Number
    K211801
    Device Name
    SPRINT PNS System
    Manufacturer
    SPR Therapeutics, Inc.
    Date Cleared
    2021-10-13

    (125 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPRINT PNS System is indicated for up to 60 days for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - · Symptomatic relief of post-traumatic pain; - · Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
    Device Description
    The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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    K Number
    K202660
    Device Name
    SPRINT PNS System
    Manufacturer
    SPR Therapeutics, Inc.
    Date Cleared
    2021-01-22

    (130 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - · Symptomatic relief of post-traumatic pain; - · Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.
    Device Description
    The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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    K Number
    K181422
    Device Name
    SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
    Manufacturer
    SPR Therapeutics, Inc.
    Date Cleared
    2018-07-31

    (61 days)

    Product Code
    NHI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPR Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; - · Symptomatic relief of post-traumatic pain; - · Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.
    Device Description
    The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, stimulator programming by the clinician, and stimulator use by the patient.
    Ask a Question

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