LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231691
    Device Name
    Phantom XL Insulated Dilators
    Manufacturer
    TeDan Surgical Innovations Inc.
    Date Cleared
    2023-06-29

    (20 days)

    Product Code
    GXZ, PDQ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    TeDan Surgical Innovations Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.
    Device Description
    TSI's Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes. They are supplied sterile, are non-pyrogenic, and are intended for single use only.
    Ask a Question

    Page 1 of 1