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

    SPRINT Peripheral Nerve Stimulation (PNS) System

    K Number: K223306 · Decision Jan 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    SPRINT Peripheral Nerve Stimulation (PNS) System
    K Number
    K223306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spr Therapeutics, Inc.
    Date Received
    October 27, 2022
    Decision Date
    January 25, 2023
    Product Code
    NHI
    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
    NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

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    Other Clearances by Spr Therapeutics, Inc.

    K Number Device Name
    K240974 SPRINT PNS System
    K211801 SPRINT PNS System
    K202660 SPRINT PNS System
    K181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit