BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Medispine - Spinal Needle, Glospine - Spinal Needle

    K Number: K212982 · Decision Jul 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    2
    Review Days
    315

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    Basic Information

    Device Name
    Medispine - Spinal Needle, Glospine - Spinal Needle
    K Number
    K212982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Global Medikit Limited
    Date Received
    September 17, 2021
    Decision Date
    July 29, 2022
    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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