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

    MANAN SPRITACRE SPINAL NEEDLES

    K Number: K011209 · Decision Jun 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    39
    Review Days
    68

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    Basic Information

    Device Name
    MANAN SPRITACRE SPINAL NEEDLES
    K Number
    K011209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Manan Medical Products, Inc.
    Date Received
    April 19, 2001
    Decision Date
    June 26, 2001
    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 Manan Medical Products, Inc.

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    K980536 EPIDURAL NEEDLE
    K981386 MANAN BLUNT NEEDLE
    K980211 MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
    K974446 MANAN AUTOMATIC CUTTING NEEDLE
    K962977 MRI COMPATIBLE BIOPSY NEEDLES
    K963767 MANAN V.S. ACCESS NEEDLE/SET
    K961986 MANAN D BAG
    K962001 MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
    Search all 39 clearances from Manan Medical Products, Inc. →