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510(k) Data Aggregation

    K Number
    K080771
    Device Name
    TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
    Manufacturer
    TOP CORP.
    Date Cleared
    2008-11-10

    (236 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Top Neuropole Needles are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
    Device Description
    Top Neuropole Needles are injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.
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    K Number
    K062946
    Device Name
    TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
    Manufacturer
    TOP CORP.
    Date Cleared
    2007-02-15

    (140 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Top Neuropole Needles are injection needles used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
    Device Description
    Top Neuropole Needles are teflon insulated injection needles for safe thermolesion procedures and regional anesthesia. There are 5 models offered, the ST, X, RC, XE and TL. The Top Neuropole Needle models TL, XE and RC are for pain management, while models ST and X are for local anesthesia. The needles are available in multiple sizes. The needle gauge ranges from 20 to 24 and the length from 30 to 200 mm. They are for single use only and supplied sterile. They may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either through the needle or by injecting contrast medium through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.
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