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

    Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

    K Number: K161154 · Decision Jul 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
    K Number
    K161154
    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, LLC
    Date Received
    April 25, 2016
    Decision Date
    July 23, 2016
    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

    Similar 510(k) Clearances

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

    SPRINT Peripheral Nerve Stimulation (PNS) System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Primary Relief

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANSiStim-PP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Primary Relief

    FDA 510(k)
    FDA Class 2 ·Neurology

    First Relief

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPRINT PNS System

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Spr Therapeutics, LLC

    K Number Device Name
    K170902 Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit