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

    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

    K Number: K162161 · Decision Dec 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    8
    Review Days
    136

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    Basic Information

    Device Name
    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
    K Number
    K162161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stimwave Technologies Incorporated
    Date Received
    August 2, 2016
    Decision Date
    December 16, 2016
    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)

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    Other Clearances by Stimwave Technologies Incorporated

    K Number Device Name
    K182720 Freedom Spinal Cord Stimulator (SCS) System
    K180981 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
    K172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
    K170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
    K160600 Freedom Spinal Cord Stimulator System
    K150517 Freedom Spinal Cord Stimulator System
    K141399 FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM