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

    IO-FLEX CATHETER

    K Number: K102594 · Decision Jan 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    10
    Review Days
    132

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    Basic Information

    Device Name
    IO-FLEX CATHETER
    K Number
    K102594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxano, Inc.
    Date Received
    September 9, 2010
    Decision Date
    January 19, 2011
    Product Code
    BSO
    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
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Baxano, Inc.

    K Number Device Name
    K113073 IO-TOME DEVICE
    K113533 NEURO CHECK DEVICE WITH IO-FLEX WIRE
    K110696 NEURO CHECK DEVICE WITH IO-FLEX WIRE
    K100958 MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
    K092729 BAXANO NEURO CHECK DEVICE
    K081742 BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
    K080494 BAXANO ULTRA LOW PROFILE RONGEUR
    K063231 MICROBLADE SHAVER AND ACCESSORIES
    K062711 ULTRA LOW PROFILE RONGEUR