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

    SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

    K Number: K151069 · Decision Feb 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    6
    Review Days
    290

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    Basic Information

    Device Name
    SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
    K Number
    K151069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectra Medical Devices, Inc.
    Date Received
    April 21, 2015
    Decision Date
    February 5, 2016
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by Spectra Medical Devices, Inc.

    K Number Device Name
    K103740 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    K082689 STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    K082580 SPECTRA GUIDEWIRE INTRODUCER NEEDLE
    K082674 SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
    K081524 SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L